Trial Outcomes & Findings for A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes) (NCT NCT03192176)
NCT ID: NCT03192176
Last Updated: 2024-11-26
Results Overview
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
356 participants
Primary outcome timeframe
Baseline and week 4
Results posted on
2024-11-26
Participant Flow
Postmenopausal women participants 40 to 65 years of age who had at least 50 moderate to severe vasomotor symptoms (VMS) per week and who met the inclusion criteria and none of the exclusion criteria were enrolled in this study.
Prior to randomization, participants had a screening period during which a minimum 7-day collection of baseline VMS frequency and severity assessments were performed.
Participant milestones
| Measure |
Placebo BID
Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks.
|
Fezolinetant 15 mg BID
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
Participants received fezolinetant 30 mg capsules orally, once daily (QD) and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 120 mg QD
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
44
|
45
|
44
|
45
|
45
|
44
|
|
Overall Study
Treated
|
43
|
45
|
43
|
45
|
44
|
43
|
45
|
44
|
|
Overall Study
COMPLETED
|
37
|
40
|
38
|
33
|
32
|
34
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
6
|
12
|
12
|
11
|
9
|
7
|
Reasons for withdrawal
| Measure |
Placebo BID
Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks.
|
Fezolinetant 15 mg BID
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
Participants received fezolinetant 30 mg capsules orally, once daily (QD) and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 120 mg QD
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
5
|
3
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
3
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
0
|
4
|
3
|
4
|
4
|
2
|
|
Overall Study
Miscellaneous
|
1
|
0
|
1
|
1
|
1
|
2
|
0
|
1
|
Baseline Characteristics
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
Baseline characteristics by cohort
| Measure |
Placebo BID
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=45 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=44 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=45 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 5.5 • n=43 Participants
|
53.7 years
STANDARD_DEVIATION 5.0 • n=45 Participants
|
53.9 years
STANDARD_DEVIATION 3.8 • n=43 Participants
|
54.6 years
STANDARD_DEVIATION 5.0 • n=45 Participants
|
54.9 years
STANDARD_DEVIATION 4.0 • n=44 Participants
|
52.7 years
STANDARD_DEVIATION 3.8 • n=43 Participants
|
55.0 years
STANDARD_DEVIATION 4.9 • n=45 Participants
|
56.8 years
STANDARD_DEVIATION 4.4 • n=44 Participants
|
54.6 years
STANDARD_DEVIATION 4.7 • n=352 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=43 Participants
|
45 Participants
n=45 Participants
|
43 Participants
n=43 Participants
|
45 Participants
n=45 Participants
|
44 Participants
n=44 Participants
|
43 Participants
n=43 Participants
|
45 Participants
n=45 Participants
|
44 Participants
n=44 Participants
|
352 Participants
n=352 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=43 Participants
|
16 Participants
n=45 Participants
|
9 Participants
n=43 Participants
|
13 Participants
n=45 Participants
|
10 Participants
n=44 Participants
|
17 Participants
n=43 Participants
|
12 Participants
n=45 Participants
|
9 Participants
n=44 Participants
|
101 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=43 Participants
|
29 Participants
n=45 Participants
|
34 Participants
n=43 Participants
|
32 Participants
n=45 Participants
|
34 Participants
n=44 Participants
|
26 Participants
n=43 Participants
|
33 Participants
n=45 Participants
|
35 Participants
n=44 Participants
|
251 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=352 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=43 Participants
|
8 Participants
n=45 Participants
|
12 Participants
n=43 Participants
|
15 Participants
n=45 Participants
|
8 Participants
n=44 Participants
|
11 Participants
n=43 Participants
|
10 Participants
n=45 Participants
|
13 Participants
n=44 Participants
|
87 Participants
n=352 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=43 Participants
|
37 Participants
n=45 Participants
|
31 Participants
n=43 Participants
|
28 Participants
n=45 Participants
|
36 Participants
n=44 Participants
|
31 Participants
n=43 Participants
|
34 Participants
n=45 Participants
|
30 Participants
n=44 Participants
|
257 Participants
n=352 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=43 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=352 Participants
|
|
Frequency of Moderate and Severe Vasomotor Symptoms per 24h
|
9.71 VMS per day
STANDARD_DEVIATION 3.53 • n=43 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
11.12 VMS per day
STANDARD_DEVIATION 7.13 • n=45 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.85 VMS per day
STANDARD_DEVIATION 4.62 • n=43 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.48 VMS per day
STANDARD_DEVIATION 3.97 • n=45 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.32 VMS per day
STANDARD_DEVIATION 3.59 • n=42 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
11.18 VMS per day
STANDARD_DEVIATION 6.44 • n=43 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.42 VMS per day
STANDARD_DEVIATION 2.70 • n=44 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.65 VMS per day
STANDARD_DEVIATION 3.73 • n=44 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
9.97 VMS per day
STANDARD_DEVIATION 4.71 • n=349 Participants • The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.
|
|
Severity of Moderate and Severe Vasomotor Symptoms per 24h
|
2.46 Score on a scale
STANDARD_DEVIATION 0.31 • n=43 Participants • FAS Population
|
2.45 Score on a scale
STANDARD_DEVIATION 0.27 • n=45 Participants • FAS Population
|
2.43 Score on a scale
STANDARD_DEVIATION 0.31 • n=43 Participants • FAS Population
|
2.45 Score on a scale
STANDARD_DEVIATION 0.31 • n=45 Participants • FAS Population
|
2.38 Score on a scale
STANDARD_DEVIATION 0.30 • n=42 Participants • FAS Population
|
2.43 Score on a scale
STANDARD_DEVIATION 0.30 • n=43 Participants • FAS Population
|
2.40 Score on a scale
STANDARD_DEVIATION 0.26 • n=44 Participants • FAS Population
|
2.49 Score on a scale
STANDARD_DEVIATION 0.32 • n=44 Participants • FAS Population
|
2.44 Score on a scale
STANDARD_DEVIATION 0.30 • n=349 Participants • FAS Population
|
|
Frequency of Mild, Moderate, and Severe Vasomotor Symptoms per 24h
|
9.96 VMS per day
STANDARD_DEVIATION 3.49 • n=43 Participants • FAS Population
|
11.63 VMS per day
STANDARD_DEVIATION 7.10 • n=45 Participants • FAS Population
|
10.33 VMS per day
STANDARD_DEVIATION 4.88 • n=43 Participants • FAS Population
|
10.14 VMS per day
STANDARD_DEVIATION 4.22 • n=45 Participants • FAS Population
|
9.85 VMS per day
STANDARD_DEVIATION 4.31 • n=42 Participants • FAS Population
|
11.72 VMS per day
STANDARD_DEVIATION 6.66 • n=43 Participants • FAS Population
|
10.15 VMS per day
STANDARD_DEVIATION 2.86 • n=44 Participants • FAS Population
|
10.15 VMS per day
STANDARD_DEVIATION 3.78 • n=44 Participants • FAS Population
|
10.5 VMS per day
STANDARD_DEVIATION 4.88 • n=349 Participants • FAS Population
|
|
Severity of Mild, Moderate, and Severe Vasomotor Symptoms per 24h
|
2.43 Score on a scale
STANDARD_DEVIATION 0.32 • n=43 Participants • FAS Population
|
2.38 Score on a scale
STANDARD_DEVIATION 0.29 • n=45 Participants • FAS Population
|
2.37 Score on a scale
STANDARD_DEVIATION 0.33 • n=43 Participants • FAS Population
|
2.38 Score on a scale
STANDARD_DEVIATION 0.36 • n=45 Participants • FAS Population
|
2.33 Score on a scale
STANDARD_DEVIATION 0.33 • n=42 Participants • FAS Population
|
2.38 Score on a scale
STANDARD_DEVIATION 0.34 • n=43 Participants • FAS Population
|
2.31 Score on a scale
STANDARD_DEVIATION 0.31 • n=44 Participants • FAS Population
|
2.43 Score on a scale
STANDARD_DEVIATION 0.37 • n=44 Participants • FAS Population
|
2.38 Score on a scale
STANDARD_DEVIATION 0.33 • n=349 Participants • FAS Population
|
PRIMARY outcome
Timeframe: Baseline and week 4Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=42 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=40 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=37 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=40 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4
|
-6.6 VMS per day
Standard Error 0.63
|
-4.2 VMS per day
Standard Error 0.65
|
-6.1 VMS per day
Standard Error 0.65
|
-7.2 VMS per day
Standard Error 0.64
|
-7.0 VMS per day
Standard Error 0.62
|
-7.7 VMS per day
Standard Error 0.65
|
-6.5 VMS per day
Standard Error 0.65
|
-7.2 VMS per day
Standard Error 0.61
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=38 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=37 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=31 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=31 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=36 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12
|
-7.4 VMS per day
Standard Error 0.57
|
-5.3 VMS per day
Standard Error 0.58
|
-7.2 VMS per day
Standard Error 0.54
|
-7.5 VMS per day
Standard Error 0.56
|
-7.6 VMS per day
Standard Error 0.55
|
-8.0 VMS per day
Standard Error 0.58
|
-7.4 VMS per day
Standard Error 0.58
|
-7.9 VMS per day
Standard Error 0.54
|
PRIMARY outcome
Timeframe: Baseline and week 4Population: FAS population with available data at specified time point.
Severity of moderate to severe VMS per day was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=42 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=40 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=37 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=40 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4
|
-1.0 Score on a scale
Standard Error 0.15
|
-0.3 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.14
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.14
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at specified time point.
Severity of moderate to severe VMS per day was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=38 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=37 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=31 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=31 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=36 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12
|
-1.1 Score on a scale
Standard Error 0.16
|
-0.8 Score on a scale
Standard Error 0.16
|
-1.0 Score on a scale
Standard Error 0.15
|
-1.1 Score on a scale
Standard Error 0.16
|
-1.3 Score on a scale
Standard Error 0.16
|
-1.4 Score on a scale
Standard Error 0.17
|
-0.9 Score on a scale
Standard Error 0.16
|
-1.3 Score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 1
|
-4.8 VMS per day
Standard Error 0.59
|
-2.0 VMS per day
Standard Error 0.60
|
-3.4 VMS per day
Standard Error 0.56
|
-4.7 VMS per day
Standard Error 0.59
|
-5.5 VMS per day
Standard Error 0.58
|
-6.1 VMS per day
Standard Error 0.61
|
-3.0 VMS per day
Standard Error 0.61
|
-4.4 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 2
|
-6.0 VMS per day
Standard Error 0.61
|
-3.6 VMS per day
Standard Error 0.62
|
-4.9 VMS per day
Standard Error 0.58
|
-6.3 VMS per day
Standard Error 0.61
|
-6.8 VMS per day
Standard Error 0.60
|
-7.3 VMS per day
Standard Error 0.63
|
-5.1 VMS per day
Standard Error 0.63
|
-5.4 VMS per day
Standard Error 0.59
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 3
|
-6.6 VMS per day
Standard Error 0.62
|
-3.8 VMS per day
Standard Error 0.63
|
-5.6 VMS per day
Standard Error 0.60
|
-6.8 VMS per day
Standard Error 0.62
|
-7.3 VMS per day
Standard Error 0.61
|
7.7 VMS per day
Standard Error 0.64
|
-5.8 VMS per day
Standard Error 0.64
|
-6.1 VMS per day
Standard Error 0.60
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 4
|
-7.1 VMS per day
Standard Error 0.62
|
-4.0 VMS per day
Standard Error 0.63
|
-5.7 VMS per day
Standard Error 0.60
|
-7.0 VMS per day
Standard Error 0.62
|
-7.2 VMS per day
Standard Error 0.61
|
-8.1 VMS per day
Standard Error 0.64
|
-6.0 VMS per day
Standard Error 0.64
|
-6.8 VMS per day
Standard Error 0.60
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 5
|
-7.1 VMS per day
Standard Error 0.59
|
-4.6 VMS per day
Standard Error 0.60
|
-5.8 VMS per day
Standard Error 0.57
|
-7.2 VMS per day
Standard Error 0.59
|
-7.6 VMS per day
Standard Error 0.58
|
-8.5 VMS per day
Standard Error 0.61
|
-6.6 VMS per day
Standard Error 0.61
|
-6.8 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 6
|
-7.6 VMS per day
Standard Error 0.59
|
-4.9 VMS per day
Standard Error 0.60
|
-6.2 VMS per day
Standard Error 0.57
|
-7.2 VMS per day
Standard Error 0.59
|
-8.0 VMS per day
Standard Error 0.58
|
-8.6 VMS per day
Standard Error 0.62
|
-6.6 VMS per day
Standard Error 0.61
|
-7.1 VMS per day
Standard Error 0.57
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 7
|
-7.7 VMS per day
Standard Error 0.60
|
-4.9 VMS per day
Standard Error 0.61
|
-6.2 VMS per day
Standard Error 0.58
|
-7.4 VMS per day
Standard Error 0.60
|
-7.8 VMS per day
Standard Error 0.59
|
-8.7 VMS per day
Standard Error 0.63
|
-6.8 VMS per day
Standard Error 0.62
|
-7.2 VMS per day
Standard Error 0.58
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 8
|
-7.8 VMS per day
Standard Error 0.61
|
-5.5 VMS per day
Standard Error 0.61
|
-6.2 VMS per day
Standard Error 0.58
|
-7.5 VMS per day
Standard Error 0.60
|
-8.1 VMS per day
Standard Error 0.60
|
-8.5 VMS per day
Standard Error 0.63
|
-6.8 VMS per day
Standard Error 0.63
|
-7.4 VMS per day
Standard Error 0.58
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 9
|
-7.9 VMS per day
Standard Error 0.58
|
-5.8 VMS per day
Standard Error 0.59
|
-6.8 VMS per day
Standard Error 0.55
|
-7.5 VMS per day
Standard Error 0.57
|
-8.3 VMS per day
Standard Error 0.57
|
-8.7 VMS per day
Standard Error 0.60
|
-6.8 VMS per day
Standard Error 0.60
|
-7.7 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 10
|
-8.0 VMS per day
Standard Error 0.60
|
-5.6 VMS per day
Standard Error 0.60
|
-7.0 VMS per day
Standard Error 0.57
|
-7.1 VMS per day
Standard Error 0.59
|
-8.3 VMS per day
Standard Error 0.59
|
-8.7 VMS per day
Standard Error 0.62
|
-7.2 VMS per day
Standard Error 0.62
|
-7.8 VMS per day
Standard Error 0.58
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 11
|
-8.0 VMS per day
Standard Error 0.59
|
-5.7 VMS per day
Standard Error 0.59
|
-7.0 VMS per day
Standard Error 0.56
|
-7.5 VMS per day
Standard Error 0.58
|
-8.7 VMS per day
Standard Error 0.58
|
-8.6 VMS per day
Standard Error 0.61
|
-7.3 VMS per day
Standard Error 0.60
|
-8.0 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 12
|
-8.1 VMS per day
Standard Error 0.57
|
-5.7 VMS per day
Standard Error 0.58
|
-7.1 VMS per day
Standard Error 0.54
|
-7.6 VMS per day
Standard Error 0.57
|
-8.5 VMS per day
Standard Error 0.57
|
-8.8 VMS per day
Standard Error 0.59
|
-7.4 VMS per day
Standard Error 0.59
|
-8.0 VMS per day
Standard Error 0.55
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 13
|
-5.5 VMS per day
Standard Error 0.61
|
-4.7 VMS per day
Standard Error 0.65
|
-5.9 VMS per day
Standard Error 0.58
|
-5.1 VMS per day
Standard Error 0.60
|
-4.9 VMS per day
Standard Error 0.63
|
-5.7 VMS per day
Standard Error 0.64
|
-6.1 VMS per day
Standard Error 0.65
|
-5.9 VMS per day
Standard Error 0.62
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 14
|
-5.1 VMS per day
Standard Error 0.61
|
-4.4 VMS per day
Standard Error 0.65
|
-5.2 VMS per day
Standard Error 0.58
|
-4.5 VMS per day
Standard Error 0.60
|
-4.5 VMS per day
Standard Error 0.63
|
-5.0 VMS per day
Standard Error 0.64
|
-5.6 VMS per day
Standard Error 0.65
|
-5.7 VMS per day
Standard Error 0.63
|
|
Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week
Week 15
|
-4.7 VMS per day
Standard Error 0.59
|
-4.9 VMS per day
Standard Error 0.62
|
-4.5 VMS per day
Standard Error 0.56
|
-4.7 VMS per day
Standard Error 0.58
|
-4.2 VMS per day
Standard Error 0.62
|
-4.5 VMS per day
Standard Error 0.62
|
-4.6 VMS per day
Standard Error 0.64
|
-5.6 VMS per day
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 10
|
-7.6 VMS per day
Standard Error 0.59
|
-5.4 VMS per day
Standard Error 0.59
|
-7.2 VMS per day
Standard Error 0.56
|
-7.5 VMS per day
Standard Error 0.58
|
-7.9 VMS per day
Standard Error 0.58
|
-8.3 VMS per day
Standard Error 0.61
|
-7.4 VMS per day
Standard Error 0.60
|
-7.8 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 5
|
-6.7 VMS per day
Standard Error 0.57
|
-4.5 VMS per day
Standard Error 0.58
|
-6.3 VMS per day
Standard Error 0.55
|
-7.6 VMS per day
Standard Error 0.57
|
-7.3 VMS per day
Standard Error 0.56
|
-8.3 VMS per day
Standard Error 0.59
|
-6.9 VMS per day
Standard Error 0.59
|
-7.3 VMS per day
Standard Error 0.55
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 14
|
-4.8 VMS per day
Standard Error 0.63
|
-4.1 VMS per day
Standard Error 0.66
|
-5.7 VMS per day
Standard Error 0.60
|
-4.5 VMS per day
Standard Error 0.61
|
-4.8 VMS per day
Standard Error 0.65
|
-5.0 VMS per day
Standard Error 0.66
|
-6.2 VMS per day
Standard Error 0.67
|
-5.8 VMS per day
Standard Error 0.65
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 15
|
-4.4 VMS per day
Standard Error 0.61
|
-4.6 VMS per day
Standard Error 0.65
|
-5.1 VMS per day
Standard Error 0.59
|
-4.5 VMS per day
Standard Error 0.60
|
-4.5 VMS per day
Standard Error 0.65
|
-4.4 VMS per day
Standard Error 0.65
|
-5.6 VMS per day
Standard Error 0.67
|
-5.5 VMS per day
Standard Error 0.65
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 1
|
-4.7 VMS per day
Standard Error 0.58
|
-2.1 VMS per day
Standard Error 0.59
|
-3.8 VMS per day
Standard Error 0.56
|
-5.3 VMS per day
Standard Error 0.58
|
-5.7 VMS per day
Standard Error 0.57
|
-6.4 VMS per day
Standard Error 0.60
|
-3.3 VMS per day
Standard Error 0.60
|
-4.7 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 2
|
-5.7 VMS per day
Standard Error 0.59
|
-3.7 VMS per day
Standard Error 0.60
|
-5.3 VMS per day
Standard Error 0.57
|
-6.8 VMS per day
Standard Error 0.59
|
-6.8 VMS per day
Standard Error 0.58
|
-7.3 VMS per day
Standard Error 0.61
|
-5.4 VMS per day
Standard Error 0.61
|
-6.0 VMS per day
Standard Error 0.57
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 3
|
-6.3 VMS per day
Standard Error 0.60
|
-3.7 VMS per day
Standard Error 0.61
|
-5.8 VMS per day
Standard Error 0.58
|
-7.3 VMS per day
Standard Error 0.60
|
-7.0 VMS per day
Standard Error 0.59
|
-7.7 VMS per day
Standard Error 0.62
|
-6.3 VMS per day
Standard Error 0.62
|
-6.9 VMS per day
Standard Error 0.58
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 6
|
-7.1 VMS per day
Standard Error 0.58
|
-4.8 VMS per day
Standard Error 0.58
|
-6.6 VMS per day
Standard Error 0.55
|
-7.5 VMS per day
Standard Error 0.57
|
-7.6 VMS per day
Standard Error 0.57
|
-8.3 VMS per day
Standard Error 0.60
|
-7.0 VMS per day
Standard Error 0.60
|
-7.5 VMS per day
Standard Error 0.55
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 7
|
-7.2 VMS per day
Standard Error 0.59
|
-4.9 VMS per day
Standard Error 0.59
|
-6.5 VMS per day
Standard Error 0.56
|
-7.7 VMS per day
Standard Error 0.58
|
-7.5 VMS per day
Standard Error 0.58
|
-8.4 VMS per day
Standard Error 0.61
|
-7.1 VMS per day
Standard Error 0.60
|
-7.4 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 8
|
-7.3 VMS per day
Standard Error 0.59
|
-5.5 VMS per day
Standard Error 0.59
|
-6.6 VMS per day
Standard Error 0.56
|
-7.6 VMS per day
Standard Error 0.58
|
-7.7 VMS per day
Standard Error 0.58
|
-8.3 VMS per day
Standard Error 0.61
|
-7.1 VMS per day
Standard Error 0.61
|
-7.7 VMS per day
Standard Error 0.56
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 9
|
-7.3 VMS per day
Standard Error 0.57
|
-5.7 VMS per day
Standard Error 0.57
|
-7.1 VMS per day
Standard Error 0.54
|
-7.7 VMS per day
Standard Error 0.56
|
-8.0 VMS per day
Standard Error 0.56
|
-8.4 VMS per day
Standard Error 0.59
|
-7.1 VMS per day
Standard Error 0.59
|
-7.9 VMS per day
Standard Error 0.54
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 11
|
-7.6 VMS per day
Standard Error 0.57
|
-5.5 VMS per day
Standard Error 0.57
|
-7.3 VMS per day
Standard Error 0.54
|
-7.8 VMS per day
Standard Error 0.56
|
-8.3 VMS per day
Standard Error 0.56
|
-8.3 VMS per day
Standard Error 0.59
|
-7.6 VMS per day
Standard Error 0.58
|
-8.0 VMS per day
Standard Error 0.54
|
|
Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week
Week 13
|
-5.2 VMS per day
Standard Error 0.61
|
-4.4 VMS per day
Standard Error 0.65
|
-6.4 VMS per day
Standard Error 0.58
|
-5.4 VMS per day
Standard Error 0.60
|
-5.3 VMS per day
Standard Error 0.63
|
-5.7 VMS per day
Standard Error 0.64
|
-6.8 VMS per day
Standard Error 0.65
|
-6.0 VMS per day
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
Severity of mild, moderate \& severe VMS per day was calculated as follows \[(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot \& was sweating \& needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 1
|
-0.5 Score on a scale
Standard Error 0.09
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.5 Score on a scale
Standard Error 0.08
|
-0.5 Score on a scale
Standard Error 0.09
|
-0.6 Score on a scale
Standard Error 0.09
|
-0.8 Score on a scale
Standard Error 0.09
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.5 Score on a scale
Standard Error 0.08
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 2
|
-0.8 Score on a scale
Standard Error 0.11
|
-0.2 Score on a scale
Standard Error 0.11
|
-0.6 Score on a scale
Standard Error 0.11
|
-0.7 Score on a scale
Standard Error 0.11
|
-1.0 Score on a scale
Standard Error 0.11
|
-1.1 Score on a scale
Standard Error 0.11
|
-0.4 Score on a scale
Standard Error 0.11
|
-0.7 Score on a scale
Standard Error 0.11
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 3
|
-1.0 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
-0.8 Score on a scale
Standard Error 0.12
|
-0.9 Score on a scale
Standard Error 0.13
|
-1.1 Score on a scale
Standard Error 0.12
|
-1.2 Score on a scale
Standard Error 0.13
|
-0.6 Score on a scale
Standard Error 0.13
|
-0.9 Score on a scale
Standard Error 0.12
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 4
|
-1.1 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
-0.8 Score on a scale
Standard Error 0.12
|
-1.0 Score on a scale
Standard Error 0.13
|
-1.1 Score on a scale
Standard Error 0.13
|
-1.4 Score on a scale
Standard Error 0.13
|
-0.8 Score on a scale
Standard Error 0.13
|
-0.9 Score on a scale
Standard Error 0.12
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 5
|
-1.0 Score on a scale
Standard Error 0.13
|
-0.5 Score on a scale
Standard Error 0.13
|
-0.8 Score on a scale
Standard Error 0.13
|
-1.0 Score on a scale
Standard Error 0.13
|
-1.3 Score on a scale
Standard Error 0.13
|
-1.5 Score on a scale
Standard Error 0.14
|
-0.8 Score on a scale
Standard Error 0.14
|
-0.9 Score on a scale
Standard Error 0.13
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 6
|
-1.2 Score on a scale
Standard Error 0.14
|
-0.5 Score on a scale
Standard Error 0.14
|
-0.9 Score on a scale
Standard Error 0.13
|
-1.0 Score on a scale
Standard Error 0.14
|
-1.4 Score on a scale
Standard Error 0.14
|
-1.6 Score on a scale
Standard Error 0.14
|
-0.8 Score on a scale
Standard Error 0.14
|
-1.0 Score on a scale
Standard Error 0.13
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 7
|
-1.2 Score on a scale
Standard Error 0.14
|
-0.5 Score on a scale
Standard Error 0.14
|
-0.9 Score on a scale
Standard Error 0.14
|
-1.1 Score on a scale
Standard Error 0.14
|
-1.4 Score on a scale
Standard Error 0.14
|
-1.6 Score on a scale
Standard Error 0.15
|
-1.0 Score on a scale
Standard Error 0.14
|
-1.0 Score on a scale
Standard Error 0.14
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 9
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.15
|
-1.1 Score on a scale
Standard Error 0.14
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 8
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.15
|
-1.0 Score on a scale
Standard Error 0.14
|
-1.2 Score on a scale
Standard Error 0.15
|
-1.5 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.1 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 10
|
-1.4 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.14
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.5 Score on a scale
Standard Error 0.15
|
-1.7 Score on a scale
Standard Error 0.15
|
-1.0 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.14
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 11
|
-1.4 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.15
|
-1.1 Score on a scale
Standard Error 0.14
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-1.8 Score on a scale
Standard Error 0.15
|
-1.0 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 12
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.15
|
-1.3 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.16
|
-1.0 Score on a scale
Standard Error 0.15
|
-1.3 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 13
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.1 Score on a scale
Standard Error 0.10
|
-0.5 Score on a scale
Standard Error 0.09
|
-0.3 Score on a scale
Standard Error 0.09
|
-0.4 Score on a scale
Standard Error 0.09
|
-0.3 Score on a scale
Standard Error 0.09
|
-0.5 Score on a scale
Standard Error 0.10
|
-0.4 Score on a scale
Standard Error 0.09
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 14
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.1 Score on a scale
Standard Error 0.10
|
-0.3 Score on a scale
Standard Error 0.08
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.3 Score on a scale
Standard Error 0.09
|
-0.1 Score on a scale
Standard Error 0.09
|
-0.4 Score on a scale
Standard Error 0.09
|
-0.3 Score on a scale
Standard Error 0.09
|
|
Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week
Week 15
|
-0.1 Score on a scale
Standard Error 0.09
|
0.0 Score on a scale
Standard Error 0.10
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.2 Score on a scale
Standard Error 0.09
|
-0.4 Score on a scale
Standard Error 0.10
|
-0.1 Score on a scale
Standard Error 0.09
|
-0.5 Score on a scale
Standard Error 0.10
|
-0.3 Score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15Population: FAS population with available data at specified time point.
Severity of moderate to severe VMS per day was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 1
|
-0.4 Score on a scale
Standard Error 0.10
|
-0.1 Score on a scale
Standard Error 0.10
|
-0.4 Score on a scale
Standard Error 0.09
|
-0.5 Score on a scale
Standard Error 0.10
|
-0.6 Score on a scale
Standard Error 0.10
|
-0.8 Score on a scale
Standard Error 0.10
|
-0.1 Score on a scale
Standard Error 0.10
|
-0.4 Score on a scale
Standard Error 0.09
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 2
|
-0.8 Score on a scale
Standard Error 0.12
|
-0.2 Score on a scale
Standard Error 0.12
|
-0.5 Score on a scale
Standard Error 0.12
|
-0.7 Score on a scale
Standard Error 0.12
|
-1.0 Score on a scale
Standard Error 0.12
|
-1.2 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
-0.6 Score on a scale
Standard Error 0.12
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 3
|
-1.0 Score on a scale
Standard Error 0.14
|
-0.2 Score on a scale
Standard Error 0.14
|
-0.7 Score on a scale
Standard Error 0.14
|
-1.0 Score on a scale
Standard Error 0.14
|
-1.2 Score on a scale
Standard Error 0.14
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.6 Score on a scale
Standard Error 0.14
|
-0.8 Score on a scale
Standard Error 0.14
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 5
|
-1.1 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.14
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.4 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.14
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 6
|
-1.3 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.5 Score on a scale
Standard Error 0.15
|
-1.6 Score on a scale
Standard Error 0.16
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.0 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 7
|
-1.2 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.9 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.15
|
-1.5 Score on a scale
Standard Error 0.15
|
-1.7 Score on a scale
Standard Error 0.16
|
-1.0 Score on a scale
Standard Error 0.16
|
-1.0 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 8
|
-1.3 Score on a scale
Standard Error 0.16
|
-0.7 Score on a scale
Standard Error 0.16
|
-1.0 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.16
|
-1.6 Score on a scale
Standard Error 0.16
|
-1.6 Score on a scale
Standard Error 0.17
|
-0.9 Score on a scale
Standard Error 0.16
|
-1.2 Score on a scale
Standard Error 0.16
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 9
|
-1.3 Score on a scale
Standard Error 0.16
|
-0.8 Score on a scale
Standard Error 0.16
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.16
|
-1.6 Score on a scale
Standard Error 0.16
|
-1.7 Score on a scale
Standard Error 0.16
|
-0.9 Score on a scale
Standard Error 0.16
|
-1.2 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 10
|
-1.4 Score on a scale
Standard Error 0.16
|
-0.8 Score on a scale
Standard Error 0.16
|
-1.2 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.16
|
-1.7 Score on a scale
Standard Error 0.16
|
-1.8 Score on a scale
Standard Error 0.16
|
-1.1 Score on a scale
Standard Error 0.16
|
-1.2 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 11
|
-1.5 Score on a scale
Standard Error 0.16
|
-0.8 Score on a scale
Standard Error 0.16
|
-1.1 Score on a scale
Standard Error 0.15
|
-1.2 Score on a scale
Standard Error 0.16
|
-1.7 Score on a scale
Standard Error 0.16
|
-1.8 Score on a scale
Standard Error 0.16
|
-1.1 Score on a scale
Standard Error 0.16
|
-1.3 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 13
|
-0.2 Score on a scale
Standard Error 0.12
|
-0.1 Score on a scale
Standard Error 0.13
|
-0.5 Score on a scale
Standard Error 0.12
|
-0.3 Score on a scale
Standard Error 0.12
|
-0.6 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
-0.6 Score on a scale
Standard Error 0.13
|
-0.4 Score on a scale
Standard Error 0.13
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 14
|
-0.2 Score on a scale
Standard Error 0.12
|
-0.1 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.11
|
-0.3 Score on a scale
Standard Error 0.11
|
-0.5 Score on a scale
Standard Error 0.12
|
-0.1 Score on a scale
Standard Error 0.12
|
-0.5 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
|
Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week
Week 15
|
-0.1 Score on a scale
Standard Error 0.12
|
0.0 Score on a scale
Standard Error 0.13
|
-0.2 Score on a scale
Standard Error 0.12
|
-0.3 Score on a scale
Standard Error 0.12
|
-0.6 Score on a scale
Standard Error 0.13
|
-0.1 Score on a scale
Standard Error 0.13
|
-0.5 Score on a scale
Standard Error 0.13
|
-0.4 Score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 14
|
-12.3 Score on a scale
Standard Error 1.57
|
-10.0 Score on a scale
Standard Error 1.66
|
-14.1 Score on a scale
Standard Error 1.50
|
-11.5 Score on a scale
Standard Error 1.53
|
-11.5 Score on a scale
Standard Error 1.63
|
-12.5 Score on a scale
Standard Error 1.66
|
-15.3 Score on a scale
Standard Error 1.67
|
-14.7 Score on a scale
Standard Error 1.62
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 15
|
-10.9 Score on a scale
Standard Error 1.51
|
-11.0 Score on a scale
Standard Error 1.59
|
-12.3 Score on a scale
Standard Error 1.46
|
-11.7 Score on a scale
Standard Error 1.48
|
-10.8 Score on a scale
Standard Error 1.61
|
-11.0 Score on a scale
Standard Error 1.60
|
-13.6 Score on a scale
Standard Error 1.65
|
-14.2 Score on a scale
Standard Error 1.59
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 1
|
-11.9 Score on a scale
Standard Error 1.45
|
-5.0 Score on a scale
Standard Error 1.48
|
-9.8 Score on a scale
Standard Error 1.39
|
-12.9 Score on a scale
Standard Error 1.45
|
-14.1 Score on a scale
Standard Error 1.42
|
-15.5 Score on a scale
Standard Error 1.50
|
-8.4 Score on a scale
Standard Error 1.50
|
-11.9 Score on a scale
Standard Error 1.39
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 2
|
-14.5 Score on a scale
Standard Error 1.47
|
-8.9 Score on a scale
Standard Error 1.50
|
-13.0 Score on a scale
Standard Error 1.41
|
-16.5 Score on a scale
Standard Error 1.47
|
-17.0 Score on a scale
Standard Error 1.44
|
-18.1 Score on a scale
Standard Error 1.52
|
-13.5 Score on a scale
Standard Error 1.52
|
-14.8 Score on a scale
Standard Error 1.41
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 3
|
-15.9 Score on a scale
Standard Error 1.51
|
-8.9 Score on a scale
Standard Error 1.54
|
-14.5 Score on a scale
Standard Error 1.45
|
-17.6 Score on a scale
Standard Error 1.51
|
-17.7 Score on a scale
Standard Error 1.48
|
-19.1 Score on a scale
Standard Error 1.57
|
-15.4 Score on a scale
Standard Error 1.56
|
-16.6 Score on a scale
Standard Error 1.45
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 4
|
-17.1 Score on a scale
Standard Error 1.51
|
-9.5 Score on a scale
Standard Error 1.53
|
-14.9 Score on a scale
Standard Error 1.45
|
-17.9 Score on a scale
Standard Error 1.51
|
-17.6 Score on a scale
Standard Error 1.47
|
-19.7 Score on a scale
Standard Error 1.57
|
-15.9 Score on a scale
Standard Error 1.56
|
-17.7 Score on a scale
Standard Error 1.45
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 5
|
-17.2 Score on a scale
Standard Error 1.44
|
-10.6 Score on a scale
Standard Error 1.45
|
-15.4 Score on a scale
Standard Error 1.37
|
-18.4 Score on a scale
Standard Error 1.43
|
-18.6 Score on a scale
Standard Error 1.40
|
-20.5 Score on a scale
Standard Error 1.49
|
-16.9 Score on a scale
Standard Error 1.48
|
-17.8 Score on a scale
Standard Error 1.37
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 6
|
-18.1 Score on a scale
Standard Error 1.43
|
-11.6 Score on a scale
Standard Error 1.44
|
-16.4 Score on a scale
Standard Error 1.36
|
-18.4 Score on a scale
Standard Error 1.42
|
-19.4 Score on a scale
Standard Error 1.39
|
-20.6 Score on a scale
Standard Error 1.48
|
-16.9 Score on a scale
Standard Error 1.47
|
-18.2 Score on a scale
Standard Error 1.36
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 7
|
-18.3 Score on a scale
Standard Error 1.45
|
-11.8 Score on a scale
Standard Error 1.46
|
-16.2 Score on a scale
Standard Error 1.38
|
-18.9 Score on a scale
Standard Error 1.44
|
-19.1 Score on a scale
Standard Error 1.41
|
-20.9 Score on a scale
Standard Error 1.50
|
-17.4 Score on a scale
Standard Error 1.49
|
-18.2 Score on a scale
Standard Error 1.39
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 8
|
-18.7 Score on a scale
Standard Error 1.45
|
-13.0 Score on a scale
Standard Error 1.46
|
-16.3 Score on a scale
Standard Error 1.38
|
-18.9 Score on a scale
Standard Error 1.44
|
-19.5 Score on a scale
Standard Error 1.42
|
-20.5 Score on a scale
Standard Error 1.51
|
-17.4 Score on a scale
Standard Error 1.50
|
-18.8 Score on a scale
Standard Error 1.39
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 9
|
-18.7 Score on a scale
Standard Error 1.39
|
-13.6 Score on a scale
Standard Error 1.40
|
-17.6 Score on a scale
Standard Error 1.32
|
-19.0 Score on a scale
Standard Error 1.37
|
-20.2 Score on a scale
Standard Error 1.36
|
-20.9 Score on a scale
Standard Error 1.44
|
-17.3 Score on a scale
Standard Error 1.43
|
-19.3 Score on a scale
Standard Error 1.33
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 10
|
-19.1 Score on a scale
Standard Error 1.44
|
-13.1 Score on a scale
Standard Error 1.44
|
-17.9 Score on a scale
Standard Error 1.37
|
-18.5 Score on a scale
Standard Error 1.42
|
-20.1 Score on a scale
Standard Error 1.41
|
-20.8 Score on a scale
Standard Error 1.49
|
-18.2 Score on a scale
Standard Error 1.48
|
-19.4 Score on a scale
Standard Error 1.38
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 11
|
-19.2 Score on a scale
Standard Error 1.41
|
-13.2 Score on a scale
Standard Error 1.41
|
-17.9 Score on a scale
Standard Error 1.33
|
-19.2 Score on a scale
Standard Error 1.39
|
-20.9 Score on a scale
Standard Error 1.38
|
-20.8 Score on a scale
Standard Error 1.46
|
-18.6 Score on a scale
Standard Error 1.45
|
-19.9 Score on a scale
Standard Error 1.35
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 12
|
-19.4 Score on a scale
Standard Error 1.38
|
-13.1 Score on a scale
Standard Error 1.38
|
-18.2 Score on a scale
Standard Error 1.31
|
-19.2 Score on a scale
Standard Error 1.36
|
-20.7 Score on a scale
Standard Error 1.35
|
-21.3 Score on a scale
Standard Error 1.43
|
-18.7 Score on a scale
Standard Error 1.42
|
-19.8 Score on a scale
Standard Error 1.32
|
|
Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week
Week 13
|
-13.3 Score on a scale
Standard Error 1.54
|
-10.7 Score on a scale
Standard Error 1.63
|
-16.0 Score on a scale
Standard Error 1.46
|
-13.6 Score on a scale
Standard Error 1.51
|
-12.7 Score on a scale
Standard Error 1.57
|
-14.4 Score on a scale
Standard Error 1.61
|
-16.3 Score on a scale
Standard Error 1.62
|
-15.3 Score on a scale
Standard Error 1.56
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 1
|
-11.8 Score on a scale
Standard Error 1.46
|
-5.1 Score on a scale
Standard Error 1.49
|
-10.2 Score on a scale
Standard Error 1.40
|
-13.4 Score on a scale
Standard Error 1.46
|
-14.3 Score on a scale
Standard Error 1.43
|
-15.7 Score on a scale
Standard Error 1.51
|
-8.8 Score on a scale
Standard Error 1.51
|
-12.2 Score on a scale
Standard Error 1.40
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 2
|
-14.3 Score on a scale
Standard Error 1.48
|
-8.9 Score on a scale
Standard Error 1.51
|
-13.5 Score on a scale
Standard Error 1.41
|
-17.0 Score on a scale
Standard Error 1.48
|
-16.9 Score on a scale
Standard Error 1.44
|
-18.2 Score on a scale
Standard Error 1.53
|
-13.8 Score on a scale
Standard Error 1.53
|
-15.5 Score on a scale
Standard Error 1.42
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 3
|
-15.6 Score on a scale
Standard Error 1.52
|
-8.9 Score on a scale
Standard Error 1.54
|
-14.8 Score on a scale
Standard Error 1.45
|
-18.2 Score on a scale
Standard Error 1.52
|
-17.5 Score on a scale
Standard Error 1.48
|
-19.1 Score on a scale
Standard Error 1.57
|
-15.9 Score on a scale
Standard Error 1.57
|
-17.3 Score on a scale
Standard Error 1.46
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 4
|
-16.7 Score on a scale
Standard Error 1.51
|
-9.5 Score on a scale
Standard Error 1.54
|
-15.2 Score on a scale
Standard Error 1.46
|
-18.3 Score on a scale
Standard Error 1.51
|
-17.4 Score on a scale
Standard Error 1.48
|
-19.6 Score on a scale
Standard Error 1.57
|
-16.4 Score on a scale
Standard Error 1.56
|
-18.0 Score on a scale
Standard Error 1.45
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 6
|
-17.6 Score on a scale
Standard Error 1.44
|
-11.5 Score on a scale
Standard Error 1.45
|
-16.7 Score on a scale
Standard Error 1.37
|
-18.7 Score on a scale
Standard Error 1.43
|
-19.0 Score on a scale
Standard Error 1.40
|
-20.3 Score on a scale
Standard Error 1.49
|
-17.3 Score on a scale
Standard Error 1.48
|
-18.6 Score on a scale
Standard Error 1.37
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 7
|
-17.8 Score on a scale
Standard Error 1.46
|
-11.8 Score on a scale
Standard Error 1.47
|
-16.6 Score on a scale
Standard Error 1.39
|
-19.2 Score on a scale
Standard Error 1.45
|
-18.7 Score on a scale
Standard Error 1.42
|
-20.6 Score on a scale
Standard Error 1.51
|
-17.7 Score on a scale
Standard Error 1.50
|
-18.5 Score on a scale
Standard Error 1.39
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 8
|
-18.2 Score on a scale
Standard Error 1.46
|
-13.0 Score on a scale
Standard Error 1.47
|
-16.6 Score on a scale
Standard Error 1.38
|
-19.1 Score on a scale
Standard Error 1.44
|
-19.1 Score on a scale
Standard Error 1.42
|
-20.2 Score on a scale
Standard Error 1.51
|
-17.7 Score on a scale
Standard Error 1.50
|
-19.0 Score on a scale
Standard Error 1.39
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 9
|
-18.2 Score on a scale
Standard Error 1.40
|
-13.5 Score on a scale
Standard Error 1.41
|
-17.9 Score on a scale
Standard Error 1.33
|
-19.3 Score on a scale
Standard Error 1.38
|
-19.8 Score on a scale
Standard Error 1.37
|
-20.5 Score on a scale
Standard Error 1.45
|
-17.7 Score on a scale
Standard Error 1.44
|
-19.4 Score on a scale
Standard Error 1.34
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 10
|
-18.7 Score on a scale
Standard Error 1.44
|
-12.9 Score on a scale
Standard Error 1.45
|
-18.2 Score on a scale
Standard Error 1.37
|
-18.9 Score on a scale
Standard Error 1.42
|
-19.7 Score on a scale
Standard Error 1.41
|
-20.4 Score on a scale
Standard Error 1.49
|
-18.4 Score on a scale
Standard Error 1.48
|
-19.5 Score on a scale
Standard Error 1.38
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 11
|
-18.8 Score on a scale
Standard Error 1.41
|
-13.0 Score on a scale
Standard Error 1.42
|
-18.2 Score on a scale
Standard Error 1.34
|
-19.4 Score on a scale
Standard Error 1.39
|
-20.5 Score on a scale
Standard Error 1.38
|
-20.5 Score on a scale
Standard Error 1.46
|
-18.9 Score on a scale
Standard Error 1.45
|
-19.9 Score on a scale
Standard Error 1.35
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 12
|
-19.0 Score on a scale
Standard Error 1.38
|
-12.8 Score on a scale
Standard Error 1.39
|
-18.4 Score on a scale
Standard Error 1.31
|
-19.3 Score on a scale
Standard Error 1.36
|
-20.3 Score on a scale
Standard Error 1.36
|
-21.0 Score on a scale
Standard Error 1.43
|
-19.0 Score on a scale
Standard Error 1.42
|
-19.8 Score on a scale
Standard Error 1.32
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 13
|
-13.0 Score on a scale
Standard Error 1.56
|
-10.4 Score on a scale
Standard Error 1.65
|
-16.4 Score on a scale
Standard Error 1.49
|
-13.8 Score on a scale
Standard Error 1.54
|
-13.1 Score on a scale
Standard Error 1.60
|
-14.4 Score on a scale
Standard Error 1.64
|
-17.0 Score on a scale
Standard Error 1.65
|
-15.4 Score on a scale
Standard Error 1.59
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 14
|
-12.0 Score on a scale
Standard Error 1.60
|
-9.7 Score on a scale
Standard Error 1.70
|
-14.5 Score on a scale
Standard Error 1.53
|
-11.5 Score on a scale
Standard Error 1.57
|
-11.7 Score on a scale
Standard Error 1.66
|
-12.5 Score on a scale
Standard Error 1.69
|
-15.9 Score on a scale
Standard Error 1.70
|
-14.6 Score on a scale
Standard Error 1.66
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 15
|
-10.6 Score on a scale
Standard Error 1.56
|
-10.7 Score on a scale
Standard Error 1.65
|
-12.9 Score on a scale
Standard Error 1.51
|
-11.6 Score on a scale
Standard Error 1.53
|
-11.1 Score on a scale
Standard Error 1.67
|
-10.9 Score on a scale
Standard Error 1.66
|
-14.7 Score on a scale
Standard Error 1.71
|
-14.1 Score on a scale
Standard Error 1.65
|
|
Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week
Week 5
|
-16.8 Score on a scale
Standard Error 1.45
|
-10.5 Score on a scale
Standard Error 1.46
|
-15.8 Score on a scale
Standard Error 1.38
|
-18.8 Score on a scale
Standard Error 1.44
|
-18.3 Score on a scale
Standard Error 1.41
|
-20.3 Score on a scale
Standard Error 1.50
|
-17.2 Score on a scale
Standard Error 1.49
|
-18.2 Score on a scale
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
44.7 Percent Reduction
Standard Error 5.22
|
14.5 Percent Reduction
Standard Error 5.33
|
29.1 Percent Reduction
Standard Error 5.01
|
37.6 Percent Reduction
Standard Error 5.21
|
51.8 Percent Reduction
Standard Error 5.12
|
55.5 Percent Reduction
Standard Error 5.39
|
22.7 Percent Reduction
Standard Error 5.40
|
40.1 Percent Reduction
Standard Error 5.02
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
56.1 Percent Reduction
Standard Error 5.21
|
30.3 Percent Reduction
Standard Error 5.30
|
46.2 Percent Reduction
Standard Error 4.99
|
54.8 Percent Reduction
Standard Error 5.20
|
64.0 Percent Reduction
Standard Error 5.09
|
68.3 Percent Reduction
Standard Error 5.39
|
44.8 Percent Reduction
Standard Error 5.38
|
49.8 Percent Reduction
Standard Error 5.01
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
62.8 Percent Reduction
Standard Error 5.56
|
32.0 Percent Reduction
Standard Error 5.66
|
52.2 Percent Reduction
Standard Error 5.37
|
60.3 Percent Reduction
Standard Error 5.58
|
68.9 Percent Reduction
Standard Error 5.44
|
72.5 Percent Reduction
Standard Error 5.77
|
51.7 Percent Reduction
Standard Error 5.75
|
56.9 Percent Reduction
Standard Error 5.37
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
67.9 Percent Reduction
Standard Error 5.50
|
34.7 Percent Reduction
Standard Error 5.58
|
55.3 Percent Reduction
Standard Error 5.33
|
63.5 Percent Reduction
Standard Error 5.52
|
68.1 Percent Reduction
Standard Error 5.39
|
76.2 Percent Reduction
Standard Error 5.72
|
54.5 Percent Reduction
Standard Error 5.69
|
64.7 Percent Reduction
Standard Error 5.30
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
66.4 Percent Reduction
Standard Error 5.28
|
41.3 Percent Reduction
Standard Error 5.32
|
56.7 Percent Reduction
Standard Error 5.08
|
66.1 Percent Reduction
Standard Error 5.26
|
72.1 Percent Reduction
Standard Error 5.17
|
80.1 Percent Reduction
Standard Error 5.49
|
60.4 Percent Reduction
Standard Error 5.42
|
63.6 Percent Reduction
Standard Error 5.06
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
74.5 Percent Reduction
Standard Error 5.11
|
50.9 Percent Reduction
Standard Error 5.13
|
60.5 Percent Reduction
Standard Error 4.87
|
69.0 Percent Reduction
Standard Error 5.05
|
76.1 Percent Reduction
Standard Error 5.01
|
81.5 Percent Reduction
Standard Error 5.32
|
62.1 Percent Reduction
Standard Error 5.26
|
69.2 Percent Reduction
Standard Error 4.90
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
76.9 Percent Reduction
Standard Error 4.87
|
53.5 Percent Reduction
Standard Error 4.88
|
68.0 Percent Reduction
Standard Error 4.63
|
68.8 Percent Reduction
Standard Error 4.81
|
80.0 Percent Reduction
Standard Error 4.81
|
83.4 Percent Reduction
Standard Error 5.05
|
67.4 Percent Reduction
Standard Error 5.02
|
75.4 Percent Reduction
Standard Error 4.66
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
47.0 Percent Reduction
Standard Error 5.72
|
39.9 Percent Reduction
Standard Error 6.12
|
42.0 Percent Reduction
Standard Error 5.50
|
41.2 Percent Reduction
Standard Error 5.60
|
39.6 Percent Reduction
Standard Error 5.99
|
43.8 Percent Reduction
Standard Error 6.08
|
41.5 Percent Reduction
Standard Error 6.14
|
52.9 Percent Reduction
Standard Error 6.01
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
43.0 Percent Reduction
Standard Error 5.64
|
45.0 Percent Reduction
Standard Error 5.97
|
37.1 Percent Reduction
Standard Error 5.49
|
42.9 Percent Reduction
Standard Error 5.56
|
37.8 Percent Reduction
Standard Error 6.06
|
39.4 Percent Reduction
Standard Error 6.01
|
32.4 Percent Reduction
Standard Error 6.21
|
51.4 Percent Reduction
Standard Error 6.00
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
72.0 Percent Reduction
Standard Error 4.97
|
45.4 Percent Reduction
Standard Error 5.01
|
60.0 Percent Reduction
Standard Error 4.74
|
65.3 Percent Reduction
Standard Error 4.93
|
75.1 Percent Reduction
Standard Error 4.86
|
81.1 Percent Reduction
Standard Error 5.16
|
60.1 Percent Reduction
Standard Error 5.12
|
65.9 Percent Reduction
Standard Error 4.75
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
72.2 Percent Reduction
Standard Error 5.14
|
45.1 Percent Reduction
Standard Error 5.17
|
59.6 Percent Reduction
Standard Error 4.92
|
68.1 Percent Reduction
Standard Error 5.10
|
74.0 Percent Reduction
Standard Error 5.05
|
81.9 Percent Reduction
Standard Error 5.34
|
60.7 Percent Reduction
Standard Error 5.29
|
66.3 Percent Reduction
Standard Error 4.93
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
74.5 Percent Reduction
Standard Error 4.88
|
53.8 Percent Reduction
Standard Error 4.90
|
65.7 Percent Reduction
Standard Error 4.64
|
68.4 Percent Reduction
Standard Error 4.81
|
78.2 Percent Reduction
Standard Error 4.78
|
83.4 Percent Reduction
Standard Error 5.06
|
62.2 Percent Reduction
Standard Error 5.03
|
72.3 Percent Reduction
Standard Error 4.67
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
76.2 Percent Reduction
Standard Error 5.02
|
51.8 Percent Reduction
Standard Error 5.03
|
67.6 Percent Reduction
Standard Error 4.78
|
64.6 Percent Reduction
Standard Error 4.95
|
77.6 Percent Reduction
Standard Error 4.95
|
83.4 Percent Reduction
Standard Error 5.20
|
66.1 Percent Reduction
Standard Error 5.17
|
73.0 Percent Reduction
Standard Error 4.82
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
76.4 Percent Reduction
Standard Error 4.86
|
53.2 Percent Reduction
Standard Error 4.87
|
68.0 Percent Reduction
Standard Error 4.62
|
70.2 Percent Reduction
Standard Error 4.80
|
79.6 Percent Reduction
Standard Error 4.80
|
84.2 Percent Reduction
Standard Error 5.04
|
68.0 Percent Reduction
Standard Error 5.01
|
75.1 Percent Reduction
Standard Error 4.65
|
|
Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
48.0 Percent Reduction
Standard Error 5.32
|
43.6 Percent Reduction
Standard Error 5.69
|
53.3 Percent Reduction
Standard Error 5.07
|
45.9 Percent Reduction
Standard Error 5.24
|
45.1 Percent Reduction
Standard Error 5.47
|
50.7 Percent Reduction
Standard Error 5.59
|
49.3 Percent Reduction
Standard Error 5.66
|
54.0 Percent Reduction
Standard Error 5.44
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
47.0 Percent Reduction
Standard Error 5.40
|
17.5 Percent Reduction
Standard Error 5.51
|
36.6 Percent Reduction
Standard Error 5.18
|
44.5 Percent Reduction
Standard Error 5.39
|
57.0 Percent Reduction
Standard Error 5.30
|
62.3 Percent Reduction
Standard Error 5.57
|
29.6 Percent Reduction
Standard Error 5.59
|
45.3 Percent Reduction
Standard Error 5.20
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
57.7 Percent Reduction
Standard Error 5.25
|
33.8 Percent Reduction
Standard Error 5.34
|
53.7 Percent Reduction
Standard Error 5.01
|
62.4 Percent Reduction
Standard Error 5.23
|
67.6 Percent Reduction
Standard Error 5.12
|
73.3 Percent Reduction
Standard Error 5.42
|
51.4 Percent Reduction
Standard Error 5.41
|
57.9 Percent Reduction
Standard Error 5.03
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
68.1 Percent Reduction
Standard Error 5.49
|
38.6 Percent Reduction
Standard Error 5.57
|
61.7 Percent Reduction
Standard Error 5.31
|
70.7 Percent Reduction
Standard Error 5.50
|
70.0 Percent Reduction
Standard Error 5.37
|
80.5 Percent Reduction
Standard Error 5.71
|
64.2 Percent Reduction
Standard Error 5.68
|
70.0 Percent Reduction
Standard Error 5.28
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
74.1 Percent Reduction
Standard Error 5.08
|
54.5 Percent Reduction
Standard Error 5.09
|
68.3 Percent Reduction
Standard Error 4.81
|
74.5 Percent Reduction
Standard Error 5.01
|
76.6 Percent Reduction
Standard Error 4.96
|
84.5 Percent Reduction
Standard Error 5.28
|
69.4 Percent Reduction
Standard Error 5.23
|
74.1 Percent Reduction
Standard Error 4.85
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
42.9 Percent Reduction
Standard Error 6.12
|
45.6 Percent Reduction
Standard Error 6.49
|
44.7 Percent Reduction
Standard Error 5.98
|
45.6 Percent Reduction
Standard Error 6.04
|
46.0 Percent Reduction
Standard Error 6.61
|
41.7 Percent Reduction
Standard Error 6.54
|
45.5 Percent Reduction
Standard Error 6.76
|
53.2 Percent Reduction
Standard Error 6.57
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
63.7 Percent Reduction
Standard Error 5.52
|
34.8 Percent Reduction
Standard Error 5.61
|
58.1 Percent Reduction
Standard Error 5.31
|
69.2 Percent Reduction
Standard Error 5.53
|
70.5 Percent Reduction
Standard Error 5.40
|
77.8 Percent Reduction
Standard Error 5.73
|
60.3 Percent Reduction
Standard Error 5.71
|
66.0 Percent Reduction
Standard Error 5.32
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
67.0 Percent Reduction
Standard Error 5.28
|
43.6 Percent Reduction
Standard Error 5.31
|
63.8 Percent Reduction
Standard Error 5.06
|
74.2 Percent Reduction
Standard Error 5.25
|
72.7 Percent Reduction
Standard Error 5.17
|
83.7 Percent Reduction
Standard Error 5.49
|
68.0 Percent Reduction
Standard Error 5.42
|
70.3 Percent Reduction
Standard Error 5.04
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
71.7 Percent Reduction
Standard Error 4.99
|
48.5 Percent Reduction
Standard Error 5.02
|
67.7 Percent Reduction
Standard Error 4.75
|
72.4 Percent Reduction
Standard Error 4.94
|
75.7 Percent Reduction
Standard Error 4.87
|
84.1 Percent Reduction
Standard Error 5.19
|
68.5 Percent Reduction
Standard Error 5.14
|
72.6 Percent Reduction
Standard Error 4.76
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
71.9 Percent Reduction
Standard Error 5.14
|
49.1 Percent Reduction
Standard Error 5.16
|
66.7 Percent Reduction
Standard Error 4.90
|
74.9 Percent Reduction
Standard Error 5.09
|
74.9 Percent Reduction
Standard Error 5.04
|
85.4 Percent Reduction
Standard Error 5.34
|
69.7 Percent Reduction
Standard Error 5.28
|
72.0 Percent Reduction
Standard Error 4.91
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
73.8 Percent Reduction
Standard Error 4.90
|
56.4 Percent Reduction
Standard Error 4.91
|
72.4 Percent Reduction
Standard Error 4.64
|
74.5 Percent Reduction
Standard Error 4.82
|
79.0 Percent Reduction
Standard Error 4.78
|
85.7 Percent Reduction
Standard Error 5.08
|
70.1 Percent Reduction
Standard Error 5.05
|
76.5 Percent Reduction
Standard Error 4.68
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
76.4 Percent Reduction
Standard Error 5.03
|
53.5 Percent Reduction
Standard Error 5.03
|
74.2 Percent Reduction
Standard Error 4.77
|
72.3 Percent Reduction
Standard Error 4.95
|
77.9 Percent Reduction
Standard Error 4.95
|
85.6 Percent Reduction
Standard Error 5.21
|
72.6 Percent Reduction
Standard Error 5.18
|
76.6 Percent Reduction
Standard Error 4.81
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
77.3 Percent Reduction
Standard Error 4.82
|
55.6 Percent Reduction
Standard Error 4.82
|
74.1 Percent Reduction
Standard Error 4.55
|
75.8 Percent Reduction
Standard Error 4.75
|
80.6 Percent Reduction
Standard Error 4.73
|
85.4 Percent Reduction
Standard Error 4.99
|
75.1 Percent Reduction
Standard Error 4.96
|
79.0 Percent Reduction
Standard Error 4.59
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
76.9 Percent Reduction
Standard Error 4.84
|
55.0 Percent Reduction
Standard Error 4.85
|
74.3 Percent Reduction
Standard Error 4.58
|
75.8 Percent Reduction
Standard Error 4.77
|
80.2 Percent Reduction
Standard Error 4.77
|
86.9 Percent Reduction
Standard Error 5.02
|
75.1 Percent Reduction
Standard Error 4.99
|
77.7 Percent Reduction
Standard Error 4.61
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
48.8 Percent Reduction
Standard Error 5.63
|
44.9 Percent Reduction
Standard Error 6.02
|
61.9 Percent Reduction
Standard Error 5.37
|
51.7 Percent Reduction
Standard Error 5.55
|
52.5 Percent Reduction
Standard Error 5.78
|
55.8 Percent Reduction
Standard Error 5.92
|
61.3 Percent Reduction
Standard Error 5.98
|
56.6 Percent Reduction
Standard Error 5.76
|
|
Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
47.7 Percent Reduction
Standard Error 6.06
|
41.0 Percent Reduction
Standard Error 6.47
|
50.4 Percent Reduction
Standard Error 5.83
|
44.9 Percent Reduction
Standard Error 5.93
|
45.9 Percent Reduction
Standard Error 6.34
|
47.2 Percent Reduction
Standard Error 6.44
|
51.4 Percent Reduction
Standard Error 6.49
|
55.3 Percent Reduction
Standard Error 6.36
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 1
|
23 participants
|
5 participants
|
19 participants
|
22 participants
|
24 participants
|
25 participants
|
10 participants
|
21 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 3
|
29 participants
|
16 participants
|
26 participants
|
29 participants
|
33 participants
|
32 participants
|
26 participants
|
29 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 5
|
29 participants
|
22 participants
|
24 participants
|
31 participants
|
30 participants
|
29 participants
|
28 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 6
|
33 participants
|
24 participants
|
24 participants
|
30 participants
|
31 participants
|
28 participants
|
24 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 7
|
30 participants
|
25 participants
|
25 participants
|
32 participants
|
29 participants
|
28 participants
|
28 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 8
|
32 participants
|
26 participants
|
28 participants
|
32 participants
|
32 participants
|
28 participants
|
25 participants
|
31 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 10
|
32 participants
|
23 participants
|
28 participants
|
26 participants
|
26 participants
|
31 participants
|
26 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 12
|
32 participants
|
21 participants
|
27 participants
|
27 participants
|
27 participants
|
28 participants
|
24 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 2
|
28 participants
|
14 participants
|
26 participants
|
29 participants
|
32 participants
|
30 participants
|
22 participants
|
26 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 4
|
31 participants
|
19 participants
|
26 participants
|
29 participants
|
31 participants
|
31 participants
|
25 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 9
|
31 participants
|
27 participants
|
29 participants
|
33 participants
|
31 participants
|
31 participants
|
25 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 11
|
31 participants
|
23 participants
|
28 participants
|
30 participants
|
25 participants
|
30 participants
|
27 participants
|
33 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 13
|
17 participants
|
12 participants
|
19 participants
|
17 participants
|
14 participants
|
15 participants
|
16 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 14
|
17 participants
|
11 participants
|
14 participants
|
15 participants
|
10 participants
|
13 participants
|
15 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 15
|
13 participants
|
14 participants
|
10 participants
|
12 participants
|
6 participants
|
9 participants
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 1
|
16 participants
|
2 participants
|
6 participants
|
11 participants
|
17 participants
|
18 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 2
|
21 participants
|
9 participants
|
15 participants
|
19 participants
|
26 participants
|
24 participants
|
13 participants
|
13 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 4
|
26 participants
|
10 participants
|
14 participants
|
22 participants
|
24 participants
|
30 participants
|
19 participants
|
24 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 10
|
24 participants
|
16 participants
|
21 participants
|
20 participants
|
23 participants
|
29 participants
|
21 participants
|
26 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 11
|
28 participants
|
19 participants
|
25 participants
|
23 participants
|
24 participants
|
28 participants
|
20 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 12
|
27 participants
|
18 participants
|
21 participants
|
22 participants
|
25 participants
|
26 participants
|
22 participants
|
26 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 3
|
26 participants
|
11 participants
|
17 participants
|
20 participants
|
27 participants
|
27 participants
|
17 participants
|
16 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 5
|
25 participants
|
15 participants
|
17 participants
|
21 participants
|
26 participants
|
29 participants
|
22 participants
|
22 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 6
|
26 participants
|
14 participants
|
18 participants
|
21 participants
|
27 participants
|
28 participants
|
19 participants
|
22 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 7
|
25 participants
|
15 participants
|
19 participants
|
24 participants
|
25 participants
|
28 participants
|
20 participants
|
22 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 8
|
26 participants
|
18 participants
|
19 participants
|
25 participants
|
24 participants
|
27 participants
|
19 participants
|
21 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 9
|
26 participants
|
18 participants
|
21 participants
|
22 participants
|
27 participants
|
28 participants
|
19 participants
|
24 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 13
|
11 participants
|
4 participants
|
12 participants
|
7 participants
|
9 participants
|
7 participants
|
10 participants
|
5 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 14
|
10 participants
|
8 participants
|
6 participants
|
5 participants
|
3 participants
|
2 participants
|
7 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 15
|
7 participants
|
8 participants
|
4 participants
|
5 participants
|
3 participants
|
0 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 1
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
6 participants
|
6 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 5
|
18 participants
|
6 participants
|
7 participants
|
11 participants
|
18 participants
|
20 participants
|
9 participants
|
10 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 6
|
21 participants
|
9 participants
|
9 participants
|
16 participants
|
21 participants
|
23 participants
|
9 participants
|
9 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 10
|
20 participants
|
13 participants
|
12 participants
|
14 participants
|
20 participants
|
26 participants
|
11 participants
|
15 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 11
|
20 participants
|
14 participants
|
13 participants
|
13 participants
|
19 participants
|
25 participants
|
12 participants
|
18 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 14
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 2
|
12 participants
|
2 participants
|
5 participants
|
6 participants
|
15 participants
|
16 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 3
|
17 participants
|
4 participants
|
9 participants
|
9 participants
|
19 participants
|
16 participants
|
6 participants
|
9 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 4
|
18 participants
|
6 participants
|
10 participants
|
12 participants
|
19 participants
|
17 participants
|
7 participants
|
12 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 7
|
20 participants
|
6 participants
|
8 participants
|
15 participants
|
20 participants
|
24 participants
|
10 participants
|
12 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 8
|
22 participants
|
13 participants
|
11 participants
|
17 participants
|
22 participants
|
23 participants
|
10 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 9
|
20 participants
|
13 participants
|
11 participants
|
15 participants
|
21 participants
|
25 participants
|
10 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 12
|
20 participants
|
13 participants
|
15 participants
|
15 participants
|
17 participants
|
22 participants
|
10 participants
|
16 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 13
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 1
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 2
|
4 participants
|
1 participants
|
2 participants
|
0 participants
|
5 participants
|
7 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 3
|
9 participants
|
1 participants
|
3 participants
|
3 participants
|
9 participants
|
8 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 5
|
6 participants
|
3 participants
|
2 participants
|
3 participants
|
10 participants
|
10 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 6
|
12 participants
|
1 participants
|
6 participants
|
3 participants
|
11 participants
|
13 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 7
|
14 participants
|
1 participants
|
5 participants
|
5 participants
|
13 participants
|
11 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 11
|
13 participants
|
3 participants
|
7 participants
|
7 participants
|
13 participants
|
17 participants
|
7 participants
|
8 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 12
|
10 participants
|
8 participants
|
7 participants
|
10 participants
|
11 participants
|
14 participants
|
5 participants
|
12 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 14
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 4
|
8 participants
|
1 participants
|
2 participants
|
4 participants
|
6 participants
|
11 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 8
|
14 participants
|
2 participants
|
7 participants
|
7 participants
|
15 participants
|
12 participants
|
5 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 9
|
12 participants
|
3 participants
|
7 participants
|
11 participants
|
12 participants
|
15 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 10
|
15 participants
|
4 participants
|
7 participants
|
6 participants
|
9 participants
|
16 participants
|
3 participants
|
8 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week
Week 13
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
25 participants
|
6 participants
|
21 participants
|
25 participants
|
27 participants
|
28 participants
|
14 participants
|
23 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
27 participants
|
15 participants
|
31 participants
|
31 participants
|
32 participants
|
32 participants
|
25 participants
|
29 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
29 participants
|
18 participants
|
31 participants
|
31 participants
|
33 participants
|
33 participants
|
30 participants
|
33 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
31 participants
|
23 participants
|
29 participants
|
31 participants
|
32 participants
|
32 participants
|
29 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
30 participants
|
23 participants
|
30 participants
|
34 participants
|
29 participants
|
31 participants
|
32 participants
|
35 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
32 participants
|
25 participants
|
29 participants
|
31 participants
|
31 participants
|
30 participants
|
28 participants
|
34 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
29 participants
|
26 participants
|
29 participants
|
33 participants
|
30 participants
|
30 participants
|
31 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
32 participants
|
28 participants
|
31 participants
|
33 participants
|
32 participants
|
28 participants
|
30 participants
|
33 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
29 participants
|
27 participants
|
30 participants
|
33 participants
|
32 participants
|
31 participants
|
28 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
31 participants
|
25 participants
|
31 participants
|
29 participants
|
26 participants
|
31 participants
|
29 participants
|
35 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
31 participants
|
25 participants
|
31 participants
|
31 participants
|
25 participants
|
30 participants
|
31 participants
|
34 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
31 participants
|
22 participants
|
31 participants
|
29 participants
|
27 participants
|
29 participants
|
26 participants
|
32 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
16 participants
|
12 participants
|
22 participants
|
18 participants
|
14 participants
|
18 participants
|
19 participants
|
16 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
18 participants
|
11 participants
|
19 participants
|
16 participants
|
9 participants
|
14 participants
|
18 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
13 participants
|
13 participants
|
12 participants
|
12 participants
|
8 participants
|
12 participants
|
14 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
17 participants
|
2 participants
|
11 participants
|
14 participants
|
21 participants
|
22 participants
|
6 participants
|
11 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
22 participants
|
9 participants
|
18 participants
|
25 participants
|
27 participants
|
25 participants
|
15 participants
|
20 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
25 participants
|
11 participants
|
22 participants
|
27 participants
|
28 participants
|
28 participants
|
21 participants
|
24 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
26 participants
|
19 participants
|
26 participants
|
31 participants
|
26 participants
|
28 participants
|
21 participants
|
26 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
26 participants
|
21 participants
|
26 participants
|
29 participants
|
27 participants
|
29 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
28 participants
|
21 participants
|
27 participants
|
30 participants
|
24 participants
|
28 participants
|
26 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
25 participants
|
13 participants
|
20 participants
|
29 participants
|
25 participants
|
30 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
26 participants
|
16 participants
|
20 participants
|
30 participants
|
25 participants
|
29 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
26 participants
|
18 participants
|
21 participants
|
29 participants
|
27 participants
|
28 participants
|
23 participants
|
30 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
25 participants
|
18 participants
|
23 participants
|
32 participants
|
25 participants
|
28 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
25 participants
|
18 participants
|
26 participants
|
28 participants
|
23 participants
|
29 participants
|
23 participants
|
29 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
26 participants
|
20 participants
|
24 participants
|
27 participants
|
24 participants
|
27 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
12 participants
|
5 participants
|
17 participants
|
9 participants
|
11 participants
|
8 participants
|
15 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
10 participants
|
9 participants
|
10 participants
|
8 participants
|
7 participants
|
3 participants
|
10 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
8 participants
|
7 participants
|
9 participants
|
8 participants
|
4 participants
|
1 participants
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
2 participants
|
1 participants
|
5 participants
|
3 participants
|
9 participants
|
2 participants
|
8 participants
|
3 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
18 participants
|
8 participants
|
12 participants
|
18 participants
|
23 participants
|
22 participants
|
12 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
21 participants
|
16 participants
|
17 participants
|
22 participants
|
24 participants
|
27 participants
|
12 participants
|
20 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
1 participants
|
1 participants
|
4 participants
|
3 participants
|
4 participants
|
1 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
3 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
6 participants
|
1 participants
|
4 participants
|
5 participants
|
10 participants
|
12 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
14 participants
|
3 participants
|
8 participants
|
13 participants
|
18 participants
|
21 participants
|
7 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
18 participants
|
5 participants
|
12 participants
|
15 participants
|
23 participants
|
23 participants
|
9 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
19 participants
|
8 participants
|
12 participants
|
18 participants
|
20 participants
|
24 participants
|
13 participants
|
13 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
21 participants
|
10 participants
|
13 participants
|
21 participants
|
22 participants
|
25 participants
|
12 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
21 participants
|
9 participants
|
12 participants
|
22 participants
|
21 participants
|
26 participants
|
12 participants
|
17 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
22 participants
|
14 participants
|
17 participants
|
22 participants
|
22 participants
|
27 participants
|
12 participants
|
19 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
22 participants
|
14 participants
|
18 participants
|
19 participants
|
20 participants
|
28 participants
|
16 participants
|
18 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
21 participants
|
15 participants
|
18 participants
|
20 participants
|
20 participants
|
26 participants
|
16 participants
|
21 participants
|
|
Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
22 participants
|
14 participants
|
18 participants
|
19 participants
|
18 participants
|
24 participants
|
16 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 1
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 2
|
6 participants
|
1 participants
|
2 participants
|
3 participants
|
7 participants
|
10 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 3
|
12 participants
|
1 participants
|
5 participants
|
6 participants
|
9 participants
|
12 participants
|
4 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 4
|
9 participants
|
1 participants
|
3 participants
|
8 participants
|
10 participants
|
14 participants
|
4 participants
|
8 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 5
|
8 participants
|
4 participants
|
5 participants
|
8 participants
|
10 participants
|
15 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 6
|
15 participants
|
1 participants
|
8 participants
|
10 participants
|
12 participants
|
16 participants
|
5 participants
|
6 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 7
|
15 participants
|
1 participants
|
7 participants
|
10 participants
|
14 participants
|
16 participants
|
9 participants
|
10 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 8
|
15 participants
|
4 participants
|
9 participants
|
12 participants
|
16 participants
|
16 participants
|
6 participants
|
9 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 12
|
13 participants
|
9 participants
|
8 participants
|
12 participants
|
14 participants
|
16 participants
|
9 participants
|
14 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 14
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 15
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 9
|
15 participants
|
5 participants
|
9 participants
|
12 participants
|
15 participants
|
18 participants
|
5 participants
|
12 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 10
|
17 participants
|
7 participants
|
9 participants
|
11 participants
|
16 participants
|
19 participants
|
6 participants
|
9 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 11
|
15 participants
|
5 participants
|
9 participants
|
11 participants
|
15 participants
|
19 participants
|
10 participants
|
9 participants
|
|
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week
Week 13
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
6 participants
|
1 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
32 participants
|
20 participants
|
27 participants
|
32 participants
|
35 participants
|
33 participants
|
23 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
37 participants
|
34 participants
|
35 participants
|
36 participants
|
34 participants
|
32 participants
|
33 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
37 participants
|
33 participants
|
34 participants
|
37 participants
|
33 participants
|
33 participants
|
32 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
35 participants
|
31 participants
|
34 participants
|
31 participants
|
28 participants
|
31 participants
|
31 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
25 participants
|
17 participants
|
22 participants
|
26 participants
|
16 participants
|
21 participants
|
20 participants
|
21 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
39 participants
|
29 participants
|
33 participants
|
35 participants
|
37 participants
|
35 participants
|
34 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
39 participants
|
30 participants
|
31 participants
|
34 participants
|
35 participants
|
35 participants
|
33 participants
|
40 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
36 participants
|
33 participants
|
34 participants
|
38 participants
|
33 participants
|
34 participants
|
36 participants
|
38 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
39 participants
|
33 participants
|
36 participants
|
37 participants
|
33 participants
|
33 participants
|
33 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
38 participants
|
32 participants
|
34 participants
|
36 participants
|
32 participants
|
33 participants
|
32 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
36 participants
|
34 participants
|
34 participants
|
32 participants
|
29 participants
|
33 participants
|
33 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
36 participants
|
34 participants
|
33 participants
|
34 participants
|
27 participants
|
31 participants
|
33 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
28 participants
|
17 participants
|
30 participants
|
26 participants
|
22 participants
|
22 participants
|
21 participants
|
25 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
22 participants
|
18 participants
|
18 participants
|
20 participants
|
12 participants
|
20 participants
|
12 participants
|
16 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
33 participants
|
28 participants
|
34 participants
|
32 participants
|
38 participants
|
33 participants
|
32 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
29 participants
|
14 participants
|
23 participants
|
29 participants
|
32 participants
|
28 participants
|
18 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
31 participants
|
19 participants
|
30 participants
|
30 participants
|
36 participants
|
32 participants
|
28 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
32 participants
|
24 participants
|
31 participants
|
30 participants
|
36 participants
|
34 participants
|
29 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
34 participants
|
26 participants
|
30 participants
|
32 participants
|
34 participants
|
34 participants
|
29 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
33 participants
|
29 participants
|
31 participants
|
36 participants
|
33 participants
|
33 participants
|
34 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
38 participants
|
28 participants
|
29 participants
|
33 participants
|
31 participants
|
32 participants
|
30 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
38 participants
|
30 participants
|
31 participants
|
34 participants
|
30 participants
|
32 participants
|
31 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
34 participants
|
29 participants
|
32 participants
|
29 participants
|
29 participants
|
31 participants
|
31 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
34 participants
|
30 participants
|
31 participants
|
30 participants
|
27 participants
|
30 participants
|
32 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
33 participants
|
28 participants
|
31 participants
|
31 participants
|
27 participants
|
28 participants
|
30 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
26 participants
|
16 participants
|
24 participants
|
20 participants
|
21 participants
|
18 participants
|
20 participants
|
19 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
23 participants
|
15 participants
|
18 participants
|
21 participants
|
15 participants
|
17 participants
|
17 participants
|
18 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
17 participants
|
17 participants
|
15 participants
|
18 participants
|
12 participants
|
13 participants
|
11 participants
|
14 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
34 participants
|
31 participants
|
32 participants
|
34 participants
|
32 participants
|
29 participants
|
31 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
34 participants
|
30 participants
|
32 participants
|
33 participants
|
32 participants
|
32 participants
|
31 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
29 participants
|
8 participants
|
21 participants
|
21 participants
|
26 participants
|
24 participants
|
16 participants
|
22 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
31 participants
|
18 participants
|
28 participants
|
27 participants
|
33 participants
|
31 participants
|
26 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
31 participants
|
22 participants
|
27 participants
|
28 participants
|
31 participants
|
30 participants
|
26 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
31 participants
|
24 participants
|
28 participants
|
31 participants
|
30 participants
|
33 participants
|
28 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
33 participants
|
27 participants
|
28 participants
|
27 participants
|
31 participants
|
30 participants
|
26 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
32 participants
|
27 participants
|
27 participants
|
32 participants
|
30 participants
|
30 participants
|
26 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
30 participants
|
28 participants
|
29 participants
|
32 participants
|
31 participants
|
29 participants
|
28 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
32 participants
|
28 participants
|
30 participants
|
31 participants
|
32 participants
|
31 participants
|
28 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
31 participants
|
27 participants
|
29 participants
|
27 participants
|
28 participants
|
30 participants
|
30 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
31 participants
|
27 participants
|
28 participants
|
28 participants
|
26 participants
|
30 participants
|
30 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
32 participants
|
25 participants
|
26 participants
|
28 participants
|
27 participants
|
27 participants
|
27 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
23 participants
|
12 participants
|
20 participants
|
16 participants
|
18 participants
|
17 participants
|
18 participants
|
17 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
18 participants
|
14 participants
|
16 participants
|
17 participants
|
12 participants
|
13 participants
|
16 participants
|
15 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
13 participants
|
15 participants
|
14 participants
|
13 participants
|
9 participants
|
12 participants
|
10 participants
|
12 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
26 participants
|
16 participants
|
27 participants
|
29 participants
|
33 participants
|
28 participants
|
25 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
20 participants
|
5 participants
|
17 participants
|
19 participants
|
22 participants
|
21 participants
|
13 participants
|
18 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
26 participants
|
14 participants
|
25 participants
|
24 participants
|
27 participants
|
24 participants
|
21 participants
|
23 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
27 participants
|
16 participants
|
25 participants
|
25 participants
|
29 participants
|
27 participants
|
25 participants
|
29 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
27 participants
|
17 participants
|
24 participants
|
26 participants
|
25 participants
|
28 participants
|
24 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
28 participants
|
20 participants
|
24 participants
|
26 participants
|
26 participants
|
28 participants
|
26 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
30 participants
|
22 participants
|
24 participants
|
25 participants
|
30 participants
|
27 participants
|
25 participants
|
30 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
30 participants
|
22 participants
|
27 participants
|
27 participants
|
27 participants
|
28 participants
|
24 participants
|
28 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
30 participants
|
22 participants
|
26 participants
|
26 participants
|
28 participants
|
26 participants
|
23 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
30 participants
|
26 participants
|
25 participants
|
26 participants
|
28 participants
|
28 participants
|
23 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
30 participants
|
22 participants
|
26 participants
|
23 participants
|
25 participants
|
29 participants
|
25 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
30 participants
|
24 participants
|
27 participants
|
25 participants
|
24 participants
|
27 participants
|
27 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
29 participants
|
23 participants
|
23 participants
|
26 participants
|
22 participants
|
26 participants
|
24 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
17 participants
|
9 participants
|
18 participants
|
13 participants
|
14 participants
|
14 participants
|
17 participants
|
13 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
14 participants
|
10 participants
|
15 participants
|
12 participants
|
10 participants
|
9 participants
|
16 participants
|
13 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
12 participants
|
11 participants
|
11 participants
|
9 participants
|
8 participants
|
7 participants
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
35 participants
|
34 participants
|
35 participants
|
32 participants
|
28 participants
|
33 participants
|
34 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
32 participants
|
22 participants
|
33 participants
|
32 participants
|
35 participants
|
36 participants
|
28 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
33 participants
|
30 participants
|
36 participants
|
33 participants
|
37 participants
|
36 participants
|
36 participants
|
38 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
39 participants
|
31 participants
|
33 participants
|
36 participants
|
36 participants
|
36 participants
|
37 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
35 participants
|
32 participants
|
34 participants
|
39 participants
|
32 participants
|
35 participants
|
37 participants
|
39 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
37 participants
|
35 participants
|
36 participants
|
36 participants
|
32 participants
|
33 participants
|
35 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
37 participants
|
33 participants
|
35 participants
|
37 participants
|
31 participants
|
33 participants
|
34 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
36 participants
|
34 participants
|
35 participants
|
34 participants
|
26 participants
|
32 participants
|
34 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
35 participants
|
31 participants
|
35 participants
|
31 participants
|
27 participants
|
31 participants
|
32 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
21 participants
|
18 participants
|
19 participants
|
22 participants
|
14 participants
|
19 participants
|
14 participants
|
17 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
38 participants
|
33 participants
|
35 participants
|
36 participants
|
31 participants
|
34 participants
|
34 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
39 participants
|
31 participants
|
34 participants
|
34 participants
|
34 participants
|
36 participants
|
36 participants
|
40 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
38 participants
|
33 participants
|
36 participants
|
37 participants
|
32 participants
|
33 participants
|
34 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
27 participants
|
17 participants
|
29 participants
|
27 participants
|
21 participants
|
24 participants
|
24 participants
|
22 participants
|
|
Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
25 participants
|
17 participants
|
23 participants
|
26 participants
|
17 participants
|
20 participants
|
23 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
33 participants
|
25 participants
|
32 participants
|
31 participants
|
34 participants
|
35 participants
|
33 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
34 participants
|
26 participants
|
32 participants
|
32 participants
|
33 participants
|
35 participants
|
33 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
37 participants
|
30 participants
|
33 participants
|
33 participants
|
30 participants
|
33 participants
|
33 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
37 participants
|
31 participants
|
32 participants
|
33 participants
|
29 participants
|
33 participants
|
32 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
34 participants
|
30 participants
|
32 participants
|
33 participants
|
31 participants
|
33 participants
|
33 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
34 participants
|
28 participants
|
33 participants
|
30 participants
|
28 participants
|
33 participants
|
34 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
33 participants
|
30 participants
|
32 participants
|
31 participants
|
26 participants
|
32 participants
|
34 participants
|
36 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
33 participants
|
28 participants
|
32 participants
|
31 participants
|
26 participants
|
31 participants
|
31 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
22 participants
|
15 participants
|
21 participants
|
21 participants
|
14 participants
|
18 participants
|
19 participants
|
19 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
17 participants
|
18 participants
|
17 participants
|
18 participants
|
12 participants
|
15 participants
|
13 participants
|
16 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
33 participants
|
31 participants
|
34 participants
|
36 participants
|
31 participants
|
34 participants
|
36 participants
|
37 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
32 participants
|
32 participants
|
33 participants
|
33 participants
|
31 participants
|
31 participants
|
33 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
26 participants
|
16 participants
|
25 participants
|
22 participants
|
20 participants
|
21 participants
|
22 participants
|
21 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
28 participants
|
15 participants
|
25 participants
|
30 participants
|
30 participants
|
33 participants
|
23 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
30 participants
|
22 participants
|
33 participants
|
32 participants
|
35 participants
|
34 participants
|
32 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
27 participants
|
11 participants
|
25 participants
|
23 participants
|
26 participants
|
26 participants
|
19 participants
|
26 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
26 participants
|
16 participants
|
30 participants
|
29 participants
|
32 participants
|
32 participants
|
26 participants
|
29 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
30 participants
|
23 participants
|
28 participants
|
29 participants
|
29 participants
|
31 participants
|
31 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
31 participants
|
27 participants
|
29 participants
|
31 participants
|
28 participants
|
34 participants
|
33 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
32 participants
|
28 participants
|
31 participants
|
29 participants
|
29 participants
|
31 participants
|
30 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
31 participants
|
28 participants
|
31 participants
|
32 participants
|
28 participants
|
32 participants
|
30 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
30 participants
|
29 participants
|
33 participants
|
32 participants
|
30 participants
|
30 participants
|
31 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
32 participants
|
28 participants
|
31 participants
|
30 participants
|
31 participants
|
33 participants
|
31 participants
|
34 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
31 participants
|
27 participants
|
31 participants
|
27 participants
|
26 participants
|
31 participants
|
32 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
30 participants
|
27 participants
|
31 participants
|
28 participants
|
24 participants
|
31 participants
|
33 participants
|
35 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
31 participants
|
25 participants
|
29 participants
|
28 participants
|
25 participants
|
29 participants
|
29 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
21 participants
|
13 participants
|
23 participants
|
18 participants
|
17 participants
|
19 participants
|
20 participants
|
18 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
17 participants
|
14 participants
|
19 participants
|
16 participants
|
11 participants
|
16 participants
|
18 participants
|
15 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
13 participants
|
15 participants
|
15 participants
|
12 participants
|
10 participants
|
14 participants
|
13 participants
|
11 participants
|
|
Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
31 participants
|
20 participants
|
31 participants
|
29 participants
|
31 participants
|
33 participants
|
28 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: FAS population with available data at specified time point.
The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=44 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=41 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=44 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 1
|
22 participants
|
6 participants
|
19 participants
|
22 participants
|
23 participants
|
22 participants
|
14 participants
|
17 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 2
|
24 participants
|
14 participants
|
25 participants
|
27 participants
|
27 participants
|
25 participants
|
24 participants
|
27 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 3
|
25 participants
|
16 participants
|
25 participants
|
27 participants
|
28 participants
|
28 participants
|
25 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 4
|
26 participants
|
19 participants
|
24 participants
|
28 participants
|
26 participants
|
29 participants
|
25 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 5
|
27 participants
|
23 participants
|
25 participants
|
28 participants
|
26 participants
|
28 participants
|
29 participants
|
33 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 6
|
29 participants
|
23 participants
|
26 participants
|
28 participants
|
27 participants
|
28 participants
|
27 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 7
|
29 participants
|
23 participants
|
29 participants
|
29 participants
|
25 participants
|
29 participants
|
27 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 8
|
29 participants
|
25 participants
|
26 participants
|
28 participants
|
26 participants
|
26 participants
|
27 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 9
|
29 participants
|
24 participants
|
27 participants
|
29 participants
|
26 participants
|
29 participants
|
27 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 10
|
29 participants
|
22 participants
|
27 participants
|
26 participants
|
24 participants
|
29 participants
|
29 participants
|
32 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 11
|
30 participants
|
24 participants
|
29 participants
|
27 participants
|
23 participants
|
27 participants
|
30 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 12
|
28 participants
|
23 participants
|
25 participants
|
27 participants
|
21 participants
|
26 participants
|
27 participants
|
31 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 13
|
16 participants
|
9 participants
|
20 participants
|
15 participants
|
13 participants
|
14 participants
|
20 participants
|
13 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 14
|
13 participants
|
10 participants
|
17 participants
|
13 participants
|
9 participants
|
10 participants
|
17 participants
|
12 participants
|
|
Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS Per Day From Baseline to Each Study Week
Week 15
|
12 participants
|
9 participants
|
12 participants
|
10 participants
|
8 participants
|
7 participants
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, and 15Population: FAS population with available data at specified time point.
The HFRDIS is a 10-item scale that measures a woman's perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10).
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=40 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=42 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=41 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=38 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=39 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15
Week 4
|
-3.5 Score on a scale
Standard Error 0.34
|
-2.2 Score on a scale
Standard Error 0.34
|
-3.3 Score on a scale
Standard Error 0.32
|
-3.6 Score on a scale
Standard Error 0.33
|
-3.8 Score on a scale
Standard Error 0.33
|
-3.7 Score on a scale
Standard Error 0.35
|
-2.5 Score on a scale
Standard Error 0.35
|
-3.4 Score on a scale
Standard Error 0.32
|
|
Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15
Week 8
|
-3.6 Score on a scale
Standard Error 0.35
|
-2.7 Score on a scale
Standard Error 0.34
|
-3.3 Score on a scale
Standard Error 0.33
|
-3.6 Score on a scale
Standard Error 0.34
|
-4.1 Score on a scale
Standard Error 0.35
|
-4.2 Score on a scale
Standard Error 0.36
|
-3.0 Score on a scale
Standard Error 0.36
|
-3.3 Score on a scale
Standard Error 0.33
|
|
Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15
Week 12
|
-3.9 Score on a scale
Standard Error 0.33
|
-2.9 Score on a scale
Standard Error 0.33
|
-3.6 Score on a scale
Standard Error 0.31
|
-3.8 Score on a scale
Standard Error 0.33
|
-4.3 Score on a scale
Standard Error 0.34
|
-4.2 Score on a scale
Standard Error 0.35
|
-3.3 Score on a scale
Standard Error 0.35
|
-3.5 Score on a scale
Standard Error 0.32
|
|
Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15
Week 15
|
-2.5 Score on a scale
Standard Error 0.40
|
-2.4 Score on a scale
Standard Error 0.39
|
-2.6 Score on a scale
Standard Error 0.37
|
-2.2 Score on a scale
Standard Error 0.39
|
-2.3 Score on a scale
Standard Error 0.40
|
-1.9 Score on a scale
Standard Error 0.41
|
-2.9 Score on a scale
Standard Error 0.42
|
-2.4 Score on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 15Population: FAS population with available data at specified time point.
The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like "more difficult than usual" and "easier than usual." Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=40 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=38 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=38 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=38 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 4: Integrity of Behavior Following Awaking
|
41.3 Score on a scale
Standard Error 3.56
|
41.2 Score on a scale
Standard Error 3.40
|
42.0 Score on a scale
Standard Error 3.23
|
41.5 Score on a scale
Standard Error 3.44
|
32.4 Score on a scale
Standard Error 3.44
|
38.0 Score on a scale
Standard Error 3.61
|
43.3 Score on a scale
Standard Error 3.58
|
41.8 Score on a scale
Standard Error 3.16
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 8:Ease of Getting to Sleep
|
43.7 Score on a scale
Standard Error 3.15
|
40.3 Score on a scale
Standard Error 3.09
|
39.2 Score on a scale
Standard Error 2.96
|
41.5 Score on a scale
Standard Error 3.10
|
35.6 Score on a scale
Standard Error 3.18
|
38.3 Score on a scale
Standard Error 3.28
|
41.7 Score on a scale
Standard Error 3.24
|
43.6 Score on a scale
Standard Error 2.98
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 8: Quality of Sleep
|
38.2 Score on a scale
Standard Error 3.71
|
41.1 Score on a scale
Standard Error 3.63
|
36.3 Score on a scale
Standard Error 3.52
|
39.5 Score on a scale
Standard Error 3.62
|
33.6 Score on a scale
Standard Error 3.75
|
38.6 Score on a scale
Standard Error 3.86
|
36.9 Score on a scale
Standard Error 3.83
|
37.7 Score on a scale
Standard Error 3.54
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 8:Ease of Awaking From Sleep
|
41.2 Score on a scale
Standard Error 3.43
|
40.3 Score on a scale
Standard Error 3.35
|
38.8 Score on a scale
Standard Error 3.22
|
37.5 Score on a scale
Standard Error 3.34
|
36.4 Score on a scale
Standard Error 3.46
|
41.2 Score on a scale
Standard Error 3.56
|
37.7 Score on a scale
Standard Error 3.53
|
44.3 Score on a scale
Standard Error 3.27
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 8: Integrity of Behavior Following Awake
|
40.5 Score on a scale
Standard Error 3.55
|
40.9 Score on a scale
Standard Error 3.49
|
40.6 Score on a scale
Standard Error 3.33
|
38.8 Score on a scale
Standard Error 3.47
|
35.2 Score on a scale
Standard Error 3.56
|
41.4 Score on a scale
Standard Error 3.69
|
35.9 Score on a scale
Standard Error 3.66
|
41.3 Score on a scale
Standard Error 3.36
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Wek 12: Ease of Getting Sleep
|
38.4 Score on a scale
Standard Error 3.39
|
32.0 Score on a scale
Standard Error 3.30
|
37.2 Score on a scale
Standard Error 3.04
|
38.9 Score on a scale
Standard Error 3.41
|
37.7 Score on a scale
Standard Error 3.44
|
39.6 Score on a scale
Standard Error 3.69
|
39.4 Score on a scale
Standard Error 3.78
|
41.6 Score on a scale
Standard Error 3.19
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 12: Quality of Sleep
|
36.6 Score on a scale
Standard Error 3.88
|
36.3 Score on a scale
Standard Error 3.76
|
37.2 Score on a scale
Standard Error 3.46
|
38.4 Score on a scale
Standard Error 3.89
|
36.0 Score on a scale
Standard Error 3.92
|
34.5 Score on a scale
Standard Error 4.22
|
37.1 Score on a scale
Standard Error 4.35
|
37.6 Score on a scale
Standard Error 3.64
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 12: Integrity of Behavior Following Awaking
|
39.0 Score on a scale
Standard Error 3.92
|
35.5 Score on a scale
Standard Error 3.82
|
38.3 Score on a scale
Standard Error 3.54
|
36.6 Score on a scale
Standard Error 3.90
|
37.3 Score on a scale
Standard Error 3.93
|
41.2 Score on a scale
Standard Error 4.18
|
35.2 Score on a scale
Standard Error 4.27
|
44.2 Score on a scale
Standard Error 3.67
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 12: Ease of Awaking From Sleep
|
40.9 Score on a scale
Standard Error 3.78
|
37.3 Score on a scale
Standard Error 3.68
|
37.1 Score on a scale
Standard Error 3.41
|
35.9 Score on a scale
Standard Error 3.77
|
37.4 Score on a scale
Standard Error 3.82
|
37.8 Score on a scale
Standard Error 4.06
|
37.1 Score on a scale
Standard Error 4.15
|
41.9 Score on a scale
Standard Error 3.57
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Wek 15:Ease of Getting Sleep
|
44.0 Score on a scale
Standard Error 3.64
|
39.8 Score on a scale
Standard Error 3.62
|
39.2 Score on a scale
Standard Error 3.29
|
42.8 Score on a scale
Standard Error 3.51
|
41.5 Score on a scale
Standard Error 3.59
|
49.4 Score on a scale
Standard Error 3.91
|
38.8 Score on a scale
Standard Error 3.85
|
44.8 Score on a scale
Standard Error 3.45
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 15: Quality of Sleep
|
41.4 Score on a scale
Standard Error 4.60
|
39.3 Score on a scale
Standard Error 4.54
|
34.7 Score on a scale
Standard Error 4.19
|
37.1 Score on a scale
Standard Error 4.39
|
36.2 Score on a scale
Standard Error 4.52
|
45.9 Score on a scale
Standard Error 4.95
|
33.0 Score on a scale
Standard Error 4.88
|
42.4 Score on a scale
Standard Error 4.39
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 15: Integrity of Behavior Following Awaking
|
43.8 Score on a scale
Standard Error 4.19
|
40.9 Score on a scale
Standard Error 4.15
|
35.1 Score on a scale
Standard Error 3.81
|
46.7 Score on a scale
Standard Error 4.01
|
42.8 Score on a scale
Standard Error 4.11
|
50.9 Score on a scale
Standard Error 4.48
|
35.9 Score on a scale
Standard Error 4.43
|
47.1 Score on a scale
Standard Error 3.98
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 15: Ease of Awaking From Sleep
|
45.0 Score on a scale
Standard Error 4.26
|
33.9 Score on a scale
Standard Error 4.20
|
34.9 Score on a scale
Standard Error 3.88
|
37.1 Score on a scale
Standard Error 4.08
|
36.1 Score on a scale
Standard Error 4.21
|
45.4 Score on a scale
Standard Error 4.57
|
35.6 Score on a scale
Standard Error 4.51
|
49.4 Score on a scale
Standard Error 4.08
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 4: Ease of Getting to Sleep
|
44.7 Score on a scale
Standard Error 3.32
|
40.7 Score on a scale
Standard Error 3.18
|
43.1 Score on a scale
Standard Error 3.06
|
44.6 Score on a scale
Standard Error 3.25
|
36.7 Score on a scale
Standard Error 3.25
|
41.7 Score on a scale
Standard Error 3.38
|
43.1 Score on a scale
Standard Error 3.35
|
40.3 Score on a scale
Standard Error 2.98
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 4: Quality of Sleep
|
42.4 Score on a scale
Standard Error 3.95
|
38.7 Score on a scale
Standard Error 3.75
|
40.4 Score on a scale
Standard Error 3.64
|
36.1 Score on a scale
Standard Error 3.81
|
32.8 Score on a scale
Standard Error 3.84
|
42.0 Score on a scale
Standard Error 4.00
|
36.7 Score on a scale
Standard Error 3.98
|
38.6 Score on a scale
Standard Error 3.53
|
|
Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15
Week 4: Ease of Awaking From Sleep
|
43.3 Score on a scale
Standard Error 3.48
|
43.6 Score on a scale
Standard Error 3.31
|
47.1 Score on a scale
Standard Error 3.18
|
43.9 Score on a scale
Standard Error 3.36
|
37.8 Score on a scale
Standard Error 3.38
|
41.7 Score on a scale
Standard Error 3.53
|
41.8 Score on a scale
Standard Error 3.51
|
37.5 Score on a scale
Standard Error 3.10
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, and 15Population: FAS population with available data at specified time point.
The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=40 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=42 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=41 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=39 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=40 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 4: Psychological Symptoms
|
-4.9 Score on a scale
Standard Error 0.71
|
-2.6 Score on a scale
Standard Error 0.70
|
-3.8 Score on a scale
Standard Error 0.66
|
-4.5 Score on a scale
Standard Error 0.69
|
-5.0 Score on a scale
Standard Error 0.68
|
-4.4 Score on a scale
Standard Error 0.71
|
-3.7 Score on a scale
Standard Error 0.70
|
-2.1 Score on a scale
Standard Error 0.65
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 4: Physical Symptoms
|
-1.9 Score on a scale
Standard Error 0.39
|
-1.1 Score on a scale
Standard Error 0.38
|
-1.1 Score on a scale
Standard Error 0.37
|
-1.6 Score on a scale
Standard Error 0.38
|
-1.1 Score on a scale
Standard Error 0.37
|
-1.2 Score on a scale
Standard Error 0.39
|
-1.4 Score on a scale
Standard Error 0.39
|
-0.8 Score on a scale
Standard Error 0.36
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 8: Physical Symptoms
|
-1.9 Score on a scale
Standard Error 0.40
|
-1.1 Score on a scale
Standard Error 0.40
|
-1.5 Score on a scale
Standard Error 0.39
|
-1.3 Score on a scale
Standard Error 0.40
|
-0.8 Score on a scale
Standard Error 0.40
|
-1.6 Score on a scale
Standard Error 0.41
|
-1.4 Score on a scale
Standard Error 0.41
|
-0.9 Score on a scale
Standard Error 0.39
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 8: VasomotorSymptoms Score
|
-3.0 Score on a scale
Standard Error 0.28
|
-1.9 Score on a scale
Standard Error 0.27
|
-2.5 Score on a scale
Standard Error 0.26
|
-3.0 Score on a scale
Standard Error 0.27
|
-3.4 Score on a scale
Standard Error 0.28
|
-3.5 Score on a scale
Standard Error 0.28
|
-2.2 Score on a scale
Standard Error 0.28
|
-2.9 Score on a scale
Standard Error 0.26
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 8: Sexual Dysfunction Score
|
-0.8 Score on a scale
Standard Error 0.14
|
-0.4 Score on a scale
Standard Error 0.14
|
-0.5 Score on a scale
Standard Error 0.13
|
-0.8 Score on a scale
Standard Error 0.14
|
-0.7 Score on a scale
Standard Error 0.14
|
-0.6 Score on a scale
Standard Error 0.14
|
-0.6 Score on a scale
Standard Error 0.14
|
-0.3 Score on a scale
Standard Error 0.13
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 8: Total Score
|
-10.2 Score on a scale
Standard Error 1.24
|
-6.9 Score on a scale
Standard Error 1.23
|
-9.4 Score on a scale
Standard Error 1.18
|
-9.9 Score on a scale
Standard Error 1.21
|
-9.9 Score on a scale
Standard Error 1.25
|
-10.1 Score on a scale
Standard Error 1.27
|
-7.6 Score on a scale
Standard Error 1.26
|
-7.0 Score on a scale
Standard Error 1.18
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 12: Psychological Symptoms
|
-4.9 Score on a scale
Standard Error 0.74
|
-3.3 Score on a scale
Standard Error 0.73
|
-5.0 Score on a scale
Standard Error 0.68
|
-4.9 Score on a scale
Standard Error 0.73
|
-4.8 Score on a scale
Standard Error 0.75
|
-4.3 Score on a scale
Standard Error 0.77
|
-4.4 Score on a scale
Standard Error 0.77
|
-3.6 Score on a scale
Standard Error 0.70
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 12: Physical Symptoms Score
|
-1.9 Score on a scale
Standard Error 0.39
|
-1.5 Score on a scale
Standard Error 0.38
|
-2.1 Score on a scale
Standard Error 0.36
|
-1.0 Score on a scale
Standard Error 0.39
|
-1.3 Score on a scale
Standard Error 0.40
|
-1.6 Score on a scale
Standard Error 0.41
|
-1.7 Score on a scale
Standard Error 0.41
|
-0.9 Score on a scale
Standard Error 0.37
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 12: Vasomotor Symptoms Score
|
-2.9 Score on a scale
Standard Error 0.26
|
-2.1 Score on a scale
Standard Error 0.26
|
-2.7 Score on a scale
Standard Error 0.24
|
-3.1 Score on a scale
Standard Error 0.26
|
-3.6 Score on a scale
Standard Error 0.26
|
-3.6 Score on a scale
Standard Error 0.27
|
-2.9 Score on a scale
Standard Error 0.27
|
-2.8 Score on a scale
Standard Error 0.25
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 12: Total Score
|
-10.3 Score on a scale
Standard Error 1.24
|
-7.6 Score on a scale
Standard Error 1.23
|
-10.4 Score on a scale
Standard Error 1.15
|
-10.1 Score on a scale
Standard Error 1.23
|
-10.7 Score on a scale
Standard Error 1.25
|
-10.3 Score on a scale
Standard Error 1.29
|
-9.6 Score on a scale
Standard Error 1.29
|
-7.8 Score on a scale
Standard Error 1.18
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 15: Psychological Symptoms Score ;
|
-4.1 Score on a scale
Standard Error 0.82
|
-2.7 Score on a scale
Standard Error 0.82
|
-4.6 Score on a scale
Standard Error 0.76
|
-4.3 Score on a scale
Standard Error 0.79
|
-2.7 Score on a scale
Standard Error 0.82
|
-2.3 Score on a scale
Standard Error 0.83
|
-4.4 Score on a scale
Standard Error 0.84
|
-2.6 Score on a scale
Standard Error 0.79
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 15: Physical Symptoms Score
|
-2.1 Score on a scale
Standard Error 0.43
|
-1.4 Score on a scale
Standard Error 0.43
|
-1.7 Score on a scale
Standard Error 0.40
|
-1.8 Score on a scale
Standard Error 0.42
|
-1.0 Score on a scale
Standard Error 0.42
|
-1.4 Score on a scale
Standard Error 0.43
|
-1.4 Score on a scale
Standard Error 0.44
|
-1.2 Score on a scale
Standard Error 0.41
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 15: Vasomotor Symptoms Score
|
-1.5 Score on a scale
Standard Error 0.34
|
-1.4 Score on a scale
Standard Error 0.34
|
-2.1 Score on a scale
Standard Error 0.32
|
-1.6 Score on a scale
Standard Error 0.33
|
-1.7 Score on a scale
Standard Error 0.34
|
-1.9 Score on a scale
Standard Error 0.35
|
-1.9 Score on a scale
Standard Error 0.35
|
-1.8 Score on a scale
Standard Error 0.33
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 15: Sexual Dysfunction Score
|
-0.7 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.14
|
-0.6 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.7 Score on a scale
Standard Error 0.16
|
-0.6 Score on a scale
Standard Error 0.15
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 15: Total Score
|
-8.3 Score on a scale
Standard Error 1.41
|
-6.3 Score on a scale
Standard Error 1.41
|
-9.1 Score on a scale
Standard Error 1.31
|
-8.3 Score on a scale
Standard Error 1.37
|
-6.3 Score on a scale
Standard Error 1.41
|
-6.0 Score on a scale
Standard Error 1.43
|
-8.6 Score on a scale
Standard Error 1.44
|
-6.3 Score on a scale
Standard Error 1.36
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 4: Sexual Dysfunction Score
|
-0.6 Score on a scale
Standard Error 0.13
|
-0.4 Score on a scale
Standard Error 0.13
|
-0.7 Score on a scale
Standard Error 0.12
|
-0.7 Score on a scale
Standard Error 0.13
|
-0.9 Score on a scale
Standard Error 0.13
|
-0.7 Score on a scale
Standard Error 0.13
|
-0.3 Score on a scale
Standard Error 0.13
|
-0.4 Score on a scale
Standard Error 0.12
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 4: VasomotorSymptoms Score
|
-2.9 Score on a scale
Standard Error 0.27
|
-1.7 Score on a scale
Standard Error 0.27
|
-2.1 Score on a scale
Standard Error 0.25
|
-2.7 Score on a scale
Standard Error 0.26
|
-3.3 Score on a scale
Standard Error 0.26
|
-3.2 Score on a scale
Standard Error 0.27
|
-2.2 Score on a scale
Standard Error 0.27
|
-2.6 Score on a scale
Standard Error 0.25
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 4: Total Score
|
-10.3 Score on a scale
Standard Error 1.19
|
-6.1 Score on a scale
Standard Error 1.17
|
-7.8 Score on a scale
Standard Error 1.10
|
-9.6 Score on a scale
Standard Error 1.16
|
-10.4 Score on a scale
Standard Error 1.15
|
-9.5 Score on a scale
Standard Error 1.19
|
-7.6 Score on a scale
Standard Error 1.19
|
-5.8 Score on a scale
Standard Error 1.10
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 8: Psychological Symptoms
|
-4.6 Score on a scale
Standard Error 0.73
|
-3.3 Score on a scale
Standard Error 0.71
|
-5.0 Score on a scale
Standard Error 0.69
|
-4.7 Score on a scale
Standard Error 0.71
|
-4.9 Score on a scale
Standard Error 0.73
|
-4.5 Score on a scale
Standard Error 0.74
|
-3.3 Score on a scale
Standard Error 0.73
|
-2.8 Score on a scale
Standard Error 0.69
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15
Week 12: Sexual Dysfunction Score
|
-0.6 Score on a scale
Standard Error 0.14
|
-0.5 Score on a scale
Standard Error 0.14
|
-0.7 Score on a scale
Standard Error 0.13
|
-1.1 Score on a scale
Standard Error 0.14
|
-0.9 Score on a scale
Standard Error 0.15
|
-0.8 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.15
|
-0.5 Score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8, 12, and 15Population: FAS population with available data at specified time point.
The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=40 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=42 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=41 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=41 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=39 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=40 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=43 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 4: Vasomotor Mean Score
|
-2.8 Score on a scale
Standard Error 0.32
|
-1.8 Score on a scale
Standard Error 0.32
|
-2.4 Score on a scale
Standard Error 0.30
|
-3.0 Score on a scale
Standard Error 0.32
|
-3.4 Score on a scale
Standard Error 0.31
|
-3.6 Score on a scale
Standard Error 0.32
|
-1.9 Score on a scale
Standard Error 0.32
|
-2.4 Score on a scale
Standard Error 0.30
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 4:Psychological Mean Score
|
-1.0 Score on a scale
Standard Error 0.21
|
-1.0 Score on a scale
Standard Error 0.21
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.3 Score on a scale
Standard Error 0.21
|
-1.3 Score on a scale
Standard Error 0.20
|
-1.2 Score on a scale
Standard Error 0.21
|
-0.8 Score on a scale
Standard Error 0.21
|
-0.6 Score on a scale
Standard Error 0.20
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 4: Physical Mean Score
|
-1.3 Score on a scale
Standard Error 0.19
|
-0.8 Score on a scale
Standard Error 0.18
|
-1.2 Score on a scale
Standard Error 0.17
|
-1.4 Score on a scale
Standard Error 0.18
|
-1.1 Score on a scale
Standard Error 0.18
|
-1.3 Score on a scale
Standard Error 0.19
|
-1.1 Score on a scale
Standard Error 0.19
|
-0.8 Score on a scale
Standard Error 0.17
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 4: Sexual Mean Score
|
-1.2 Score on a scale
Standard Error 0.27
|
-0.7 Score on a scale
Standard Error 0.27
|
-1.5 Score on a scale
Standard Error 0.25
|
-1.8 Score on a scale
Standard Error 0.27
|
-1.4 Score on a scale
Standard Error 0.26
|
-1.2 Score on a scale
Standard Error 0.27
|
-0.8 Score on a scale
Standard Error 0.28
|
-0.7 Score on a scale
Standard Error 0.25
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 4: Overall Mean Score
|
-1.3 Score on a scale
Standard Error 0.18
|
-0.9 Score on a scale
Standard Error 0.18
|
-1.3 Score on a scale
Standard Error 0.17
|
-1.6 Score on a scale
Standard Error 0.18
|
-1.4 Score on a scale
Standard Error 0.17
|
-1.5 Score on a scale
Standard Error 0.18
|
-1.1 Score on a scale
Standard Error 0.18
|
-0.9 Score on a scale
Standard Error 0.17
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 8: Vasomotor Mean Score
|
-3.4 Score on a scale
Standard Error 0.32
|
-2.1 Score on a scale
Standard Error 0.31
|
-2.6 Score on a scale
Standard Error 0.30
|
-3.4 Score on a scale
Standard Error 0.31
|
-3.8 Score on a scale
Standard Error 0.31
|
-4.1 Score on a scale
Standard Error 0.32
|
-2.5 Score on a scale
Standard Error 0.32
|
-3.1 Score on a scale
Standard Error 0.30
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 8: Physical Mean Score
|
-1.3 Score on a scale
Standard Error 0.19
|
-1.0 Score on a scale
Standard Error 0.19
|
-1.2 Score on a scale
Standard Error 0.18
|
-1.5 Score on a scale
Standard Error 0.19
|
-1.4 Score on a scale
Standard Error 0.19
|
-1.5 Score on a scale
Standard Error 0.19
|
-1.3 Score on a scale
Standard Error 0.19
|
-1.0 Score on a scale
Standard Error 0.18
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 8: Overall Mean Score
|
-1.5 Score on a scale
Standard Error 0.18
|
-1.2 Score on a scale
Standard Error 0.18
|
-1.3 Score on a scale
Standard Error 0.17
|
-1.7 Score on a scale
Standard Error 0.18
|
-1.6 Score on a scale
Standard Error 0.18
|
-1.7 Score on a scale
Standard Error 0.18
|
-1.4 Score on a scale
Standard Error 0.18
|
-1.2 Score on a scale
Standard Error 0.17
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 12: Vasomotor Mean Score
|
-3.6 Score on a scale
Standard Error 0.31
|
-2.3 Score on a scale
Standard Error 0.31
|
-3.2 Score on a scale
Standard Error 0.29
|
-3.5 Score on a scale
Standard Error 0.31
|
-3.8 Score on a scale
Standard Error 0.31
|
-4.4 Score on a scale
Standard Error 0.32
|
-2.9 Score on a scale
Standard Error 0.32
|
-3.3 Score on a scale
Standard Error 0.30
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 12: Sexual Score
|
-1.3 Score on a scale
Standard Error 0.29
|
-0.8 Score on a scale
Standard Error 0.29
|
-0.9 Score on a scale
Standard Error 0.27
|
-1.8 Score on a scale
Standard Error 0.29
|
-1.4 Score on a scale
Standard Error 0.29
|
-0.9 Score on a scale
Standard Error 0.30
|
-1.4 Score on a scale
Standard Error 0.31
|
-0.8 Score on a scale
Standard Error 0.28
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 12: Overall Mean Score
|
-1.6 Score on a scale
Standard Error 0.18
|
-1.3 Score on a scale
Standard Error 0.18
|
-1.5 Score on a scale
Standard Error 0.17
|
-1.8 Score on a scale
Standard Error 0.18
|
-1.7 Score on a scale
Standard Error 0.18
|
-1.7 Score on a scale
Standard Error 0.19
|
-1.5 Score on a scale
Standard Error 0.19
|
-1.3 Score on a scale
Standard Error 0.17
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 15: Vasomotor Mean Score
|
-1.3 Score on a scale
Standard Error 0.37
|
-1.8 Score on a scale
Standard Error 0.36
|
-2.1 Score on a scale
Standard Error 0.34
|
-1.7 Score on a scale
Standard Error 0.36
|
-1.4 Score on a scale
Standard Error 0.37
|
-1.7 Score on a scale
Standard Error 0.37
|
-2.1 Score on a scale
Standard Error 0.38
|
-2.2 Score on a scale
Standard Error 0.35
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 8: Psychological Mean Score
|
-1.1 Score on a scale
Standard Error 0.20
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.2 Score on a scale
Standard Error 0.19
|
-1.3 Score on a scale
Standard Error 0.20
|
-1.4 Score on a scale
Standard Error 0.20
|
-1.3 Score on a scale
Standard Error 0.21
|
-1.0 Score on a scale
Standard Error 0.20
|
-1.0 Score on a scale
Standard Error 0.19
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 8: Sexual Mean Score
|
-1.2 Score on a scale
Standard Error 0.27
|
-0.9 Score on a scale
Standard Error 0.26
|
-1.0 Score on a scale
Standard Error 0.25
|
-1.7 Score on a scale
Standard Error 0.26
|
-1.2 Score on a scale
Standard Error 0.27
|
-1.2 Score on a scale
Standard Error 0.27
|
-1.3 Score on a scale
Standard Error 0.27
|
-0.8 Score on a scale
Standard Error 0.25
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 12: Psychological Mean Score
|
-1.2 Score on a scale
Standard Error 0.21
|
-1.3 Score on a scale
Standard Error 0.20
|
-1.3 Score on a scale
Standard Error 0.19
|
-1.7 Score on a scale
Standard Error 0.20
|
-1.5 Score on a scale
Standard Error 0.21
|
-1.4 Score on a scale
Standard Error 0.22
|
-1.0 Score on a scale
Standard Error 0.22
|
-1.1 Score on a scale
Standard Error 0.20
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 12: Physical Mean Score
|
-1.4 Score on a scale
Standard Error 0.19
|
-1.3 Score on a scale
Standard Error 0.19
|
-1.4 Score on a scale
Standard Error 0.18
|
-1.6 Score on a scale
Standard Error 0.19
|
-1.4 Score on a scale
Standard Error 0.19
|
-1.5 Score on a scale
Standard Error 0.20
|
-1.4 Score on a scale
Standard Error 0.20
|
-1.0 Score on a scale
Standard Error 0.18
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 15: Psychological Mean Score
|
-1.0 Score on a scale
Standard Error 0.23
|
-1.0 Score on a scale
Standard Error 0.23
|
-1.0 Score on a scale
Standard Error 0.22
|
-1.3 Score on a scale
Standard Error 0.23
|
-1.1 Score on a scale
Standard Error 0.23
|
-0.9 Score on a scale
Standard Error 0.24
|
-1.2 Score on a scale
Standard Error 0.24
|
-0.9 Score on a scale
Standard Error 0.22
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 15: Physical Mean Score
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.3 Score on a scale
Standard Error 0.18
|
-1.5 Score on a scale
Standard Error 0.19
|
-0.9 Score on a scale
Standard Error 0.20
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.4 Score on a scale
Standard Error 0.20
|
-1.0 Score on a scale
Standard Error 0.19
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 15: Sexual Mean Score
|
-1.2 Score on a scale
Standard Error 0.30
|
-0.6 Score on a scale
Standard Error 0.30
|
-0.9 Score on a scale
Standard Error 0.28
|
-1.5 Score on a scale
Standard Error 0.30
|
-1.4 Score on a scale
Standard Error 0.30
|
-0.6 Score on a scale
Standard Error 0.31
|
-1.3 Score on a scale
Standard Error 0.32
|
-0.6 Score on a scale
Standard Error 0.29
|
|
Change From Baseline in Menopause-Specific Quality of Life (MENQoL) at Weeks 4, 8, 12, and 15
Week 15: Overall Mean Score
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.1 Score on a scale
Standard Error 0.19
|
-1.3 Score on a scale
Standard Error 0.18
|
-1.5 Score on a scale
Standard Error 0.19
|
-1.1 Score on a scale
Standard Error 0.19
|
-1.2 Score on a scale
Standard Error 0.20
|
-1.4 Score on a scale
Standard Error 0.21
|
-1.0 Score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at baseline and specified time point.
Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=30 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=28 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=28 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=35 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change Over Time From Baseline in Plasma Concentrations of Luteinizing Hormone (LH) at Week 12
|
-8.62 International unit per liter (IU/L)
Standard Deviation 11.95
|
-1.14 International unit per liter (IU/L)
Standard Deviation 8.00
|
-1.28 International unit per liter (IU/L)
Standard Deviation 8.53
|
-3.28 International unit per liter (IU/L)
Standard Deviation 8.93
|
-7.30 International unit per liter (IU/L)
Standard Deviation 15.49
|
-10.86 International unit per liter (IU/L)
Standard Deviation 12.64
|
-3.69 International unit per liter (IU/L)
Standard Deviation 11.21
|
-3.97 International unit per liter (IU/L)
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at baseline and specified time point.
Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=30 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=28 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=28 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=35 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change Over Time From Baseline in Plasma Concentrations of Follicle-Stimulating Hormone (FSH) at Week 12
|
-9.94 IU/L
Standard Deviation 16.96
|
-0.91 IU/L
Standard Deviation 9.79
|
-1.52 IU/L
Standard Deviation 12.88
|
-1.00 IU/L
Standard Deviation 13.51
|
-6.49 IU/L
Standard Deviation 25.58
|
-9.43 IU/L
Standard Deviation 17.40
|
-0.98 IU/L
Standard Deviation 26.90
|
-0.07 IU/L
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at baseline and specified time point.
Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration. The analysis value for Estradiol was imputed as 73.4/2 = 36.7 when result was \< 73.4.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=30 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=28 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=28 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=35 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change Over Time From Baseline in Plasma Concentrations of Estradiol (E2) at Week 12
|
1.32 picomole per milliliter (pmol/L)
Standard Deviation 5.68
|
1.49 picomole per milliliter (pmol/L)
Standard Deviation 7.41
|
-1.29 picomole per milliliter (pmol/L)
Standard Deviation 53.58
|
20.47 picomole per milliliter (pmol/L)
Standard Deviation 93.37
|
10.15 picomole per milliliter (pmol/L)
Standard Deviation 96.52
|
-4.85 picomole per milliliter (pmol/L)
Standard Deviation 56.56
|
-15.99 picomole per milliliter (pmol/L)
Standard Deviation 213.04
|
-32.08 picomole per milliliter (pmol/L)
Standard Deviation 198.54
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: FAS population with available data at baseline and specified time point.
Change was calculated as the post-baseline measurement minus the baseline measurement. Baseline was the last measurement taken prior to initial study drug administration.
Outcome measures
| Measure |
Fezolinetant 120 mg QD
n=36 Participants
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Placebo
n=37 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=40 Participants
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=33 Participants
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=30 Participants
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=28 Participants
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=28 Participants
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=35 Participants
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change Over Time From Baseline in Plasma Concentrations of Sex Hormone-Binding Globulin (SHBG) at Week 12
|
0.583 Nanomole per liter (nmol/L)
Standard Deviation 14.283
|
1.877 Nanomole per liter (nmol/L)
Standard Deviation 12.270
|
0.720 Nanomole per liter (nmol/L)
Standard Deviation 14.220
|
4.867 Nanomole per liter (nmol/L)
Standard Deviation 10.492
|
1.621 Nanomole per liter (nmol/L)
Standard Deviation 16.329
|
6.643 Nanomole per liter (nmol/L)
Standard Deviation 11.107
|
2.350 Nanomole per liter (nmol/L)
Standard Deviation 17.852
|
0.143 Nanomole per liter (nmol/L)
Standard Deviation 8.741
|
Adverse Events
Placebo BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fezolinetant 15 mg BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Fezolinetant 30 mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Fezolinetant 60 mg BID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Fezolinetant 90 mg BID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Fezolinetant 30 mg QD
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Fezolinetant 60 mg QD
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Fezolinetant 120 mg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo BID
n=43 participants at risk
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 participants at risk
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 participants at risk
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=45 participants at risk
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=44 participants at risk
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=43 participants at risk
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=45 participants at risk
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 120 mg QD
n=44 participants at risk
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/45 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/45 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
Other adverse events
| Measure |
Placebo BID
n=43 participants at risk
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 15 mg BID
n=45 participants at risk
Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg BID
n=43 participants at risk
Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 60 mg BID
n=45 participants at risk
Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 90 mg BID
n=44 participants at risk
Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.
|
Fezolinetant 30 mg QD
n=43 participants at risk
Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 60 mg QD
n=45 participants at risk
Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
Fezolinetant 120 mg QD
n=44 participants at risk
Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/45 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
4.5%
2/44 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
7.0%
3/43 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/44 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.7%
2/43 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
4.5%
2/44 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.5%
2/44 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/44 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/45 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/44 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
7.0%
3/43 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/44 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
4.5%
2/44 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
4.7%
2/43 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
6.8%
3/44 • Number of events 4 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/43 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
6.8%
3/44 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/45 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Nervous system disorders
Headache
|
4.7%
2/43 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
4.7%
2/43 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
4.4%
2/45 • Number of events 2 • From date of informed consent until end of the study (up to 15 weeks)
|
2.3%
1/44 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
14.0%
6/43 • Number of events 6 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
9.1%
4/44 • Number of events 4 • From date of informed consent until end of the study (up to 15 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
2.2%
1/45 • Number of events 1 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/43 • From date of informed consent until end of the study (up to 15 weeks)
|
6.7%
3/45 • Number of events 3 • From date of informed consent until end of the study (up to 15 weeks)
|
0.00%
0/44 • From date of informed consent until end of the study (up to 15 weeks)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER