Trial Outcomes & Findings for Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes (NCT NCT05419908)
NCT ID: NCT05419908
Last Updated: 2024-11-27
Results Overview
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity.
COMPLETED
PHASE2
87 participants
Baseline and week 12
2024-11-27
Participant Flow
Postmenopausal women participants between 40 to 65 years of age who had hot flashes (HF) 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 HF frequency and severity assessments were performed.
Participant milestones
| Measure |
Placebo
Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks.
|
Fezolinetant
Participants received 90 milligrams (mg) fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received fezolinetant matching placebo capsules orally, twice daily (BID) for a period of 12 weeks.
|
Fezolinetant
Participants received 90 milligrams (mg) fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Overall Study
Participant Did not Fulfill all Inclusion/Exclusion Criteria
|
1
|
0
|
|
Overall Study
Serious Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Miscellaneous
|
1
|
1
|
Baseline Characteristics
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=43 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 Years
STANDARD_DEVIATION 4.25 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 4.03 • n=7 Participants
|
53.5 Years
STANDARD_DEVIATION 4.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weekly General Hot Flash Score
|
25.76 Score on a scale
STANDARD_DEVIATION 10.26 • n=5 Participants
|
28.76 Score on a scale
STANDARD_DEVIATION 13.39 • n=7 Participants
|
27.24 Score on a scale
STANDARD_DEVIATION 11.93 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: Intent-to-treat (ITT) population (included all randomized participants who received at least one dose of the study medication and who had post-baseline efficacy data) with available data at specified time point.
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=40 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in The Weekly General Hot Flash Score
|
-12.19 score on a scale
Interval -16.55 to -7.83
|
-26.51 score on a scale
Interval -30.83 to -22.18
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HF Severity Score by method 1 takes into account the number and severity of moderate and severe HF occurred during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\]/(number of moderate HF + number of severe HF) The severity of HFs was clinically defined as follows: * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)
Week 4
|
-0.294 score on a scale
Interval -0.473 to -0.116
|
-1.428 score on a scale
Interval -1.718 to -1.138
|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)
Week 8
|
-0.608 score on a scale
Interval -0.899 to -0.318
|
-1.557 score on a scale
Interval -1.858 to -1.257
|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)
Week 12
|
-0.534 score on a scale
Interval -0.798 to -0.27
|
-1.656 score on a scale
Interval -1.937 to -1.376
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HF Severity Score by method 2 takes into account moderate and severe HF during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\] The severity of HFs was clinically defined as follows: * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)
Week 4
|
-9.55 score on a scale
Interval -12.73 to -6.36
|
-25.26 score on a scale
Interval -29.64 to -20.89
|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)
Week 8
|
-11.91 score on a scale
Interval -15.72 to -8.1
|
-25.71 score on a scale
Interval -30.15 to -21.27
|
|
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)
Week 12
|
-12.14 score on a scale
Interval -16.62 to -7.65
|
-26.61 score on a scale
Interval -31.06 to -22.17
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The weekly HF frequency was calculated as number of mild, moderate and severe hot flashes over the week. * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of hot flashes is worse.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12
Week 12
|
-35.6 HF's per day
Interval -46.7 to -24.5
|
-75.3 HF's per day
Interval -86.4 to -64.3
|
|
Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12
Week 4
|
-26.4 HF's per day
Interval -35.2 to -17.5
|
-72.3 HF's per day
Interval -82.7 to -61.8
|
|
Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12
Week 8
|
-32.9 HF's per day
Interval -43.2 to -22.7
|
-73.3 HF's per day
Interval -83.8 to -62.8
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 4
|
22.7 percentage of participants
Interval 10.34 to 35.11
|
87.8 percentage of participants
Interval 77.79 to 97.82
|
|
Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 8
|
39.0 percentage of participants
Interval 24.09 to 53.96
|
87.5 percentage of participants
Interval 77.25 to 97.75
|
|
Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 12
|
42.5 percentage of participants
Interval 27.18 to 57.82
|
95.0 percentage of participants
Interval 88.25 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HFs is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 4
|
9.1 percentage of participants
Interval 0.6 to 17.59
|
78.0 percentage of participants
Interval 65.38 to 90.72
|
|
Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 8
|
26.8 percentage of participants
Interval 13.27 to 40.39
|
77.5 percentage of participants
Interval 64.56 to 90.44
|
|
Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 12
|
30.0 percentage of participants
Interval 15.8 to 44.2
|
87.5 percentage of participants
Interval 77.25 to 97.75
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HF score (based on severity and frequency) was calculated as: (number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3) The severity of HF is clinically defined as follows: * Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 4
|
6.8 percentage of participants
Interval 0.0 to 14.27
|
61.0 percentage of participants
Interval 46.04 to 75.91
|
|
Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 8
|
12.2 percentage of participants
Interval 2.18 to 22.21
|
60.0 percentage of participants
Interval 44.82 to 75.18
|
|
Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12
Week 12
|
15.0 percentage of participants
Interval 3.93 to 26.07
|
62.5 percentage of participants
Interval 47.5 to 77.5
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 4
|
45.5 percentage of participants
Interval 30.74 to 60.17
|
95.1 percentage of participants
Interval 88.53 to 100.0
|
|
Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 8
|
53.7 percentage of participants
Interval 38.39 to 68.92
|
97.5 percentage of participants
Interval 92.66 to 100.0
|
|
Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 12
|
55.0 percentage of participants
Interval 39.58 to 70.42
|
97.5 percentage of participants
Interval 92.66 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 4
|
25.0 percentage of participants
Interval 12.21 to 37.79
|
87.8 percentage of participants
Interval 77.79 to 97.82
|
|
Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 8
|
46.3 percentage of participants
Interval 31.08 to 61.61
|
92.5 percentage of participants
Interval 84.34 to 100.0
|
|
Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 12
|
40.0 percentage of participants
Interval 24.82 to 55.18
|
97.5 percentage of participants
Interval 92.66 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week. * Moderate: 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: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of HF indicates worse symptoms.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 4
|
6.8 percentage of participants
Interval 0.0 to 14.27
|
68.3 percentage of participants
Interval 54.05 to 82.54
|
|
Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 8
|
24.4 percentage of participants
Interval 11.25 to 37.54
|
67.5 percentage of participants
Interval 52.99 to 82.01
|
|
Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12
Week 12
|
20.0 percentage of participants
Interval 7.6 to 32.4
|
72.5 percentage of participants
Interval 58.66 to 86.34
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The HFRDIS was a 10-item scale which measured a woman's perceptions of the degree to which HF interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, enjoying life); the 10th item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory both of which assessed the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which HF had interfered with each item during the previous 4-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score was calculated as sum of items/number of available items. Higher score indicate a higher interference.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Leisure Activities
|
-1.6 score on a scale
Standard Deviation 2.63
|
-4.0 score on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Leisure Activities
|
-1.7 score on a scale
Standard Deviation 2.72
|
-4.2 score on a scale
Standard Deviation 2.50
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Work
|
-1.7 score on a scale
Standard Deviation 2.93
|
-4.6 score on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Work
|
-2.4 score on a scale
Standard Deviation 2.80
|
-5.0 score on a scale
Standard Deviation 2.38
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Work
|
-2.3 score on a scale
Standard Deviation 2.58
|
-4.6 score on a scale
Standard Deviation 2.68
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Social Activities
|
-1.6 score on a scale
Standard Deviation 2.53
|
-4.3 score on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Social Activities
|
-1.9 score on a scale
Standard Deviation 2.85
|
-4.7 score on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Social Activities
|
-1.8 score on a scale
Standard Deviation 2.51
|
-4.3 score on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Leisure Activities
|
-2.0 score on a scale
Standard Deviation 2.52
|
-3.8 score on a scale
Standard Deviation 3.08
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Sleep
|
-2.5 score on a scale
Standard Deviation 2.93
|
-5.2 score on a scale
Standard Deviation 2.77
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Sleep
|
-3.2 score on a scale
Standard Deviation 3.29
|
-5.7 score on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Sleep
|
-3.3 score on a scale
Standard Deviation 3.01
|
-5.8 score on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Mood
|
-2.3 score on a scale
Standard Deviation 2.49
|
-4.0 score on a scale
Standard Deviation 2.85
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Mood
|
-2.3 score on a scale
Standard Deviation 2.86
|
-4.4 score on a scale
Standard Deviation 2.84
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Mood
|
-2.5 score on a scale
Standard Deviation 2.56
|
-4.3 score on a scale
Standard Deviation 2.64
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Concentration
|
-1.6 score on a scale
Standard Deviation 2.68
|
-3.9 score on a scale
Standard Deviation 2.57
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Concentration
|
-1.6 score on a scale
Standard Deviation 3.06
|
-4.1 score on a scale
Standard Deviation 2.59
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Concentration
|
-1.9 score on a scale
Standard Deviation 3.17
|
-4.0 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Relations With Others
|
-2.1 score on a scale
Standard Deviation 2.93
|
-3.3 score on a scale
Standard Deviation 2.45
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Relations With Others
|
-1.8 score on a scale
Standard Deviation 3.02
|
-3.5 score on a scale
Standard Deviation 2.70
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Relations With Others
|
-1.8 score on a scale
Standard Deviation 3.16
|
-3.3 score on a scale
Standard Deviation 2.67
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Sexuality
|
-1.9 score on a scale
Standard Deviation 2.88
|
-3.0 score on a scale
Standard Deviation 3.49
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Sexuality
|
-1.8 score on a scale
Standard Deviation 3.48
|
-3.2 score on a scale
Standard Deviation 3.76
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Sexuality
|
-1.7 score on a scale
Standard Deviation 2.84
|
-3.4 score on a scale
Standard Deviation 3.86
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Enjoyment of Life
|
-1.6 score on a scale
Standard Deviation 2.86
|
-3.6 score on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Enjoyment of Life
|
-1.5 score on a scale
Standard Deviation 3.15
|
-3.9 score on a scale
Standard Deviation 2.59
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Enjoyment of Life
|
-1.6 score on a scale
Standard Deviation 3.38
|
-3.7 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Overall Quality of Life
|
-1.4 score on a scale
Standard Deviation 2.43
|
-3.8 score on a scale
Standard Deviation 2.87
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Overall Quality of Life
|
-1.5 score on a scale
Standard Deviation 3.01
|
-4.5 score on a scale
Standard Deviation 1.92
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Overall Quality of Life
|
-1.6 score on a scale
Standard Deviation 3.05
|
-4.6 score on a scale
Standard Deviation 2.16
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 4: Overall Mean Score
|
-1.84 score on a scale
Standard Deviation 1.922
|
-3.97 score on a scale
Standard Deviation 2.141
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 8: Overall Mean Score
|
-1.98 score on a scale
Standard Deviation 2.439
|
-4.33 score on a scale
Standard Deviation 1.945
|
|
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12
Week 12: Overall Mean Score
|
-2.05 score on a scale
Standard Deviation 2.326
|
-4.17 score on a scale
Standard Deviation 2.067
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The LSEQ was a 10-item self-rated questionnaire which assessed participants aspects of sleep and early morning behavior. The questions were grouped into 4 chronological areas: the ease of getting to sleep, the perceived quality of sleep, the ease of awaking from sleep, and the integrity of early morning behavior following wakefulness. The LSEQ was a visual analogue scale which requires respondents to place marks on a group of 10 cm lines. representing the changes they have experienced in a variety of symptoms since the beginning of treatment. Lines extends between extremes like "more difficult than usual" and "easier than usual". Responses are measured using a 100-mm scale and are averaged to provide a score for each domain.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=41 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 4: Getting to Sleep
|
1.017 millimeter (mm)
Standard Deviation 1.9195
|
2.283 millimeter (mm)
Standard Deviation 2.7364
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 8: Getting to Sleep
|
1.145 millimeter (mm)
Standard Deviation 1.7931
|
2.248 millimeter (mm)
Standard Deviation 2.5233
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 12: Getting to Sleep
|
1.282 millimeter (mm)
Standard Deviation 1.7761
|
2.094 millimeter (mm)
Standard Deviation 2.4419
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 4: Quality of Sleep
|
2.145 millimeter (mm)
Standard Deviation 2.6443
|
4.437 millimeter (mm)
Standard Deviation 4.0768
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 8: Quality of Sleep
|
2.378 millimeter (mm)
Standard Deviation 2.8160
|
4.703 millimeter (mm)
Standard Deviation 3.1971
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 12: Quality of Sleep
|
1.904 millimeter (mm)
Standard Deviation 2.7872
|
4.385 millimeter (mm)
Standard Deviation 3.4477
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 4: Awake Following Sleep
|
0.642 millimeter (mm)
Standard Deviation 2.0739
|
2.180 millimeter (mm)
Standard Deviation 3.0579
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 8: Awake Following Sleep
|
0.653 millimeter (mm)
Standard Deviation 2.5019
|
2.920 millimeter (mm)
Standard Deviation 3.0219
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 12: Awake Following Sleep
|
1.024 millimeter (mm)
Standard Deviation 2.6114
|
2.887 millimeter (mm)
Standard Deviation 3.1333
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 4: Behavior Following Wakening
|
1.173 millimeter (mm)
Standard Deviation 2.1743
|
2.513 millimeter (mm)
Standard Deviation 2.7919
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 8: Behavior Following Wakening
|
0.750 millimeter (mm)
Standard Deviation 2.6371
|
2.539 millimeter (mm)
Standard Deviation 2.7742
|
|
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12
Week 12: Behavior Following Wakening
|
1.203 millimeter (mm)
Standard Deviation 2.5185
|
2.233 millimeter (mm)
Standard Deviation 2.8190
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The GCS was a 21-item scale which provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item was rated by the participant according to its severity using a four-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into three main independent symptom measures: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and vasomotor symptoms (items 19 to 20; score 0 to 6), by summing up the individual item scores. Item 21 is a probe for sexual dysfunction (Loss of interest in sex). The total score ranges from 0 to 63. Higher scores indicate worse symptoms.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=40 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 4: Loss of Interest in Sex
|
-0.4 score on a scale
Standard Deviation 0.67
|
-0.5 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 8: Loss of interest in Sex
|
-0.5 score on a scale
Standard Deviation 0.85
|
-0.7 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 12: Loss of Interest in Sex
|
-0.4 score on a scale
Standard Deviation 0.75
|
-0.6 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 4: Psychological
|
-2.3 score on a scale
Standard Deviation 5.22
|
-5.3 score on a scale
Standard Deviation 5.97
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 8: Psychological
|
-2.6 score on a scale
Standard Deviation 5.31
|
-6.7 score on a scale
Standard Deviation 6.49
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 12: Psychological
|
-2.9 score on a scale
Standard Deviation 5.14
|
-6.6 score on a scale
Standard Deviation 6.03
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 4: Physical
|
-2.1 score on a scale
Standard Deviation 3.68
|
-1.2 score on a scale
Standard Deviation 2.71
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 8: Physical
|
-1.9 score on a scale
Standard Deviation 3.46
|
-1.9 score on a scale
Standard Deviation 3.09
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 12: Physical
|
-2.4 score on a scale
Standard Deviation 3.80
|
-1.9 score on a scale
Standard Deviation 3.32
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 4: Vasomotor
|
-1.1 score on a scale
Standard Deviation 1.79
|
-3.3 score on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 8: Vasomotor
|
-1.7 score on a scale
Standard Deviation 2.23
|
-3.6 score on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 12: Vasomotor
|
-1.5 score on a scale
Standard Deviation 2.31
|
-3.6 score on a scale
Standard Deviation 1.37
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 4: Total Symptom Score
|
-5.5 score on a scale
Standard Deviation 9.33
|
-9.9 score on a scale
Standard Deviation 9.24
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 8: Total Symptom Score
|
-5.8 score on a scale
Standard Deviation 8.89
|
-13.1 score on a scale
Standard Deviation 10.68
|
|
Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12
Week 12: Total Symptom Score
|
-6.3 score on a scale
Standard Deviation 8.87
|
-13.1 score on a scale
Standard Deviation 10.04
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms on a 10-point visual analog scale. The 3 items could be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).Higher scores indicate significant functional impairment.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=40 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 4: Work/School
|
-1.3 score on a scale
Standard Deviation 2.43
|
-3.6 score on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 8: Work/School
|
-1.7 score on a scale
Standard Deviation 2.56
|
-4.4 score on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 12: Work/School
|
-1.8 score on a scale
Standard Deviation 2.76
|
-4.3 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 4: Social Life
|
-1.2 score on a scale
Standard Deviation 2.35
|
-3.3 score on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 8: Social Life
|
-1.3 score on a scale
Standard Deviation 2.57
|
-3.8 score on a scale
Standard Deviation 2.79
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 12: Social Life
|
-1.5 score on a scale
Standard Deviation 2.55
|
-3.6 score on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 4: Family Life/Home Responsibilities
|
-1.5 score on a scale
Standard Deviation 2.70
|
-3.3 score on a scale
Standard Deviation 2.97
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 8: Family Life/Home Responsibilities
|
-1.7 score on a scale
Standard Deviation 2.64
|
-4.0 score on a scale
Standard Deviation 2.83
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 12: Family Life/Home Responsibilities
|
-1.7 score on a scale
Standard Deviation 2.38
|
-3.7 score on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 4: Global Functional Impairment
|
-3.7 score on a scale
Standard Deviation 5.50
|
-9.6 score on a scale
Standard Deviation 6.99
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 8: Global Functional Impairment
|
-4.5 score on a scale
Standard Deviation 6.87
|
-12.3 score on a scale
Standard Deviation 6.42
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12
Week 12: Global Functional Impairment
|
-4.8 score on a scale
Standard Deviation 6.49
|
-11.8 score on a scale
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 8 and 12Population: ITT population with available data at specified time point.
The SDS was a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in a participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his/her 1- work/school, 2- social life, and 3- family life are impaired by his/her symptoms. In addition to the 3 items, the participants were asked two questions Days Lost: On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities? Day Unproductive: On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work, your productivity was reduced?
Outcome measures
| Measure |
Placebo
n=29 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=28 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 4: Days Lost
|
-0.2 days
Standard Deviation 1.27
|
0.0 days
Standard Deviation 0.73
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 8: Days Lost
|
-0.3 days
Standard Deviation 0.81
|
0.0 days
Standard Deviation 0.00
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 12: Days Lost
|
-0.2 days
Standard Deviation 1.18
|
0.0 days
Standard Deviation 0.00
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 4: Days Unproductive
|
-0.8 days
Standard Deviation 2.83
|
-1.7 days
Standard Deviation 2.67
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 8: Days Unproductive
|
-1.2 days
Standard Deviation 3.10
|
-2.0 days
Standard Deviation 2.55
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive)
Week 12: Days Unproductive
|
-1.4 days
Standard Deviation 2.82
|
-2.2 days
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12: 3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of LH was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Week 4: Pre-dose
|
-2.34 international unit per liter (IU/L)
Standard Deviation 9.350
|
-8.84 international unit per liter (IU/L)
Standard Deviation 10.865
|
|
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Week 8: Pre-dose
|
-3.86 international unit per liter (IU/L)
Standard Deviation 9.838
|
-9.46 international unit per liter (IU/L)
Standard Deviation 13.647
|
|
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Week 12: Pre-dose
|
-4.61 international unit per liter (IU/L)
Standard Deviation 13.304
|
-9.72 international unit per liter (IU/L)
Standard Deviation 12.834
|
|
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Week 12: 3 hours (h)
|
-7.16 international unit per liter (IU/L)
Standard Deviation 13.009
|
-21.78 international unit per liter (IU/L)
Standard Deviation 11.923
|
|
Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH)
Week 15
|
-6.16 international unit per liter (IU/L)
Standard Deviation 14.197
|
-3.33 international unit per liter (IU/L)
Standard Deviation 11.742
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of FSH was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Week 4: Pre-dose
|
-5.80 IU/L
Standard Deviation 19.430
|
-3.44 IU/L
Standard Deviation 18.026
|
|
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Week 8: Pre-dose
|
-6.60 IU/L
Standard Deviation 20.086
|
-10.36 IU/L
Standard Deviation 23.943
|
|
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Week 12: Pre-dose
|
-7.05 IU/L
Standard Deviation 19.978
|
-10.51 IU/L
Standard Deviation 24.521
|
|
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Week 12: 3h
|
-8.47 IU/L
Standard Deviation 19.159
|
-19.48 IU/L
Standard Deviation 22.734
|
|
Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH)
Week 15
|
-6.50 IU/L
Standard Deviation 21.011
|
-6.97 IU/L
Standard Deviation 22.273
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of E2 was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Estradiol (E2)
Week 4: Pre-dose
|
18.4 Picomoles per liter (pmol/L)
Standard Deviation 140.36
|
-7.3 Picomoles per liter (pmol/L)
Standard Deviation 75.13
|
|
Change From Baseline in Plasma Concentration of Estradiol (E2)
Week 8: Pre-dose
|
26.0 Picomoles per liter (pmol/L)
Standard Deviation 157.18
|
1.0 Picomoles per liter (pmol/L)
Standard Deviation 71.78
|
|
Change From Baseline in Plasma Concentration of Estradiol (E2)
Week 12: Pre-dose
|
32.3 Picomoles per liter (pmol/L)
Standard Deviation 101.87
|
25.5 Picomoles per liter (pmol/L)
Standard Deviation 108.27
|
|
Change From Baseline in Plasma Concentration of Estradiol (E2)
Week 12: 3h
|
26.0 Picomoles per liter (pmol/L)
Standard Deviation 100.33
|
11.5 Picomoles per liter (pmol/L)
Standard Deviation 77.68
|
|
Change From Baseline in Plasma Concentration of Estradiol (E2)
Week 15
|
37.0 Picomoles per liter (pmol/L)
Standard Deviation 167.37
|
27.9 Picomoles per liter (pmol/L)
Standard Deviation 188.18
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of SHBG was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Week 4: Pre-dose
|
0.61 Nanomoles per liter (nmol/L)
Standard Deviation 16.260
|
-0.47 Nanomoles per liter (nmol/L)
Standard Deviation 11.986
|
|
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Week 8: Pre-dose
|
5.10 Nanomoles per liter (nmol/L)
Standard Deviation 20.713
|
-1.37 Nanomoles per liter (nmol/L)
Standard Deviation 12.186
|
|
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Week 12: Pre-dose
|
1.75 Nanomoles per liter (nmol/L)
Standard Deviation 18.090
|
0.36 Nanomoles per liter (nmol/L)
Standard Deviation 15.165
|
|
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Week 12: 3h
|
1.56 Nanomoles per liter (nmol/L)
Standard Deviation 18.658
|
-1.49 Nanomoles per liter (nmol/L)
Standard Deviation 16.406
|
|
Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG)
Week 15
|
1.92 Nanomoles per liter (nmol/L)
Standard Deviation 16.341
|
-0.86 Nanomoles per liter (nmol/L)
Standard Deviation 13.540
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of leptin was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Leptin
Week 4: Pre-dose
|
1.2436 nanogram per liter (ng/mL)
Standard Deviation 5.6269
|
-2.2185 nanogram per liter (ng/mL)
Standard Deviation 6.9522
|
|
Change From Baseline in Plasma Concentration of Leptin
Week 8: Pre-dose
|
1.6225 nanogram per liter (ng/mL)
Standard Deviation 7.5029
|
-1.7090 nanogram per liter (ng/mL)
Standard Deviation 6.9716
|
|
Change From Baseline in Plasma Concentration of Leptin
Week 12: Pre-dose
|
0.9668 nanogram per liter (ng/mL)
Standard Deviation 5.4301
|
-0.4183 nanogram per liter (ng/mL)
Standard Deviation 11.0737
|
|
Change From Baseline in Plasma Concentration of Leptin
Week 12: 3h
|
-2.0755 nanogram per liter (ng/mL)
Standard Deviation 5.3193
|
-4.2085 nanogram per liter (ng/mL)
Standard Deviation 8.5335
|
|
Change From Baseline in Plasma Concentration of Leptin
Week 15
|
-0.9914 nanogram per liter (ng/mL)
Standard Deviation 14.6660
|
-0.6031 nanogram per liter (ng/mL)
Standard Deviation 8.2519
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of insulin was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Insulin
Week 4: Pre-dose
|
-0.2767 micro units per milliliter (μU/mL)
Standard Deviation 3.0971
|
-0.7512 micro units per milliliter (μU/mL)
Standard Deviation 3.8798
|
|
Change From Baseline in Plasma Concentration of Insulin
Week 8: Pre-dose
|
0.3525 micro units per milliliter (μU/mL)
Standard Deviation 4.0903
|
-0.5325 micro units per milliliter (μU/mL)
Standard Deviation 3.6121
|
|
Change From Baseline in Plasma Concentration of Insulin
Week 12: Pre-dose
|
-0.0825 micro units per milliliter (μU/mL)
Standard Deviation 3.1593
|
0.1300 micro units per milliliter (μU/mL)
Standard Deviation 4.7942
|
|
Change From Baseline in Plasma Concentration of Insulin
Week 12: 3h
|
16.3225 micro units per milliliter (μU/mL)
Standard Deviation 19.0210
|
14.4950 micro units per milliliter (μU/mL)
Standard Deviation 19.2787
|
|
Change From Baseline in Plasma Concentration of Insulin
Week 15
|
0.3256 micro units per milliliter (μU/mL)
Standard Deviation 4.1132
|
-0.1595 micro units per milliliter (μU/mL)
Standard Deviation 3.1071
|
SECONDARY outcome
Timeframe: Baseline and week 4: pre-dose, week 8:pre-dose, week 12:pre-dose, week 12:3h, follow-up (week 15)Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of C-peptide was reported.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=42 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of C-peptide
Week 12: Pre-dose
|
-0.0750 ng/mL
Standard Deviation 0.5212
|
-0.0425 ng/mL
Standard Deviation 0.7154
|
|
Change From Baseline in Plasma Concentration of C-peptide
Week 4: Pre-dose
|
-0.0465 ng/mL
Standard Deviation 0.3978
|
-0.1463 ng/mL
Standard Deviation 0.5134
|
|
Change From Baseline in Plasma Concentration of C-peptide
Week 8: Pre-dose
|
-0.0300 ng/mL
Standard Deviation 0.5273
|
-0.1175 ng/mL
Standard Deviation 0.4750
|
|
Change From Baseline in Plasma Concentration of C-peptide
Week 12: 3h
|
2.1325 ng/mL
Standard Deviation 1.9976
|
2.2875 ng/mL
Standard Deviation 2.1811
|
|
Change From Baseline in Plasma Concentration of C-peptide
Week 15
|
-0.0047 ng/mL
Standard Deviation 0.6102
|
-0.0095 ng/mL
Standard Deviation 0.4023
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: Safety population with available data at specified time point.
Change From baseline in plasma concentration of HBA1C was reported.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=39 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c)
|
-0.00050000 Percentage of HBA1c
Standard Deviation 0.003162278
|
-0.002307692 Percentage of HBA1c
Standard Deviation 0.004845800
|
SECONDARY outcome
Timeframe: From first dose of study drug until end of the study (Up to week 15)Population: Safety Population
An AE is any untoward medical occurrence in a participant administered a study drug, \& which does not necessarily have to have a causal relationship with treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with use of a medicinal product (mp) whether or not considered related to the mp. An AE is considered "serious" if it results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inparticipant hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. TEAE was defined as an AE observed from first dose date up to end of study.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=43 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE's)
At least one TEAE
|
35 participants
|
29 participants
|
|
Number of Participants With Adverse Events (AE's)
At least one serious TEAE
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE's)
At least one TEAE leading to death
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE's)
At least one severe TEAE
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE's)
At least one TEAE for which the study treatment was permanently stopped
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE's)
At least one TEAE that was considered treatment related
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: ITT population with available data at specified time point.
Change from baseline in plasma concentration of BALP was reported.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=40 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12
|
2.9 microgram per milliliter (ug/mL)
Standard Deviation 5.43
|
1.7 microgram per milliliter (ug/mL)
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: ITT population with available data at specified time point.
Change from baseline in plasma concentration of CTX was reported.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=40 Participants
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12
|
-0.021 ug/mL
Standard Deviation 0.1278
|
0.001 ug/mL
Standard Deviation 0.1356
|
Adverse Events
Placebo
Fezolinetant
Serious adverse events
| Measure |
Placebo
n=44 participants at risk
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=43 participants at risk
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.3%
1/44 • Number of events 1 • From first dose of study drug until end of the study (Up to week 15)
|
0.00%
0/43 • From first dose of study drug until end of the study (Up to week 15)
|
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.
|
Fezolinetant
n=43 participants at risk
Participants received 90 mg fezolinetant capsules orally, BID for a period of 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.5%
2/44 • Number of events 2 • From first dose of study drug until end of the study (Up to week 15)
|
7.0%
3/43 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/44 • From first dose of study drug until end of the study (Up to week 15)
|
7.0%
3/43 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
|
General disorders
Fatigue
|
0.00%
0/44 • From first dose of study drug until end of the study (Up to week 15)
|
7.0%
3/43 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
|
Infections and infestations
Influenza
|
2.3%
1/44 • Number of events 1 • From first dose of study drug until end of the study (Up to week 15)
|
7.0%
3/43 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
4/44 • Number of events 4 • From first dose of study drug until end of the study (Up to week 15)
|
4.7%
2/43 • Number of events 2 • From first dose of study drug until end of the study (Up to week 15)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.8%
3/44 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
0.00%
0/43 • From first dose of study drug until end of the study (Up to week 15)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Number of events 3 • From first dose of study drug until end of the study (Up to week 15)
|
0.00%
0/43 • From first dose of study drug until end of the study (Up to week 15)
|
|
Nervous system disorders
Headache
|
13.6%
6/44 • Number of events 10 • From first dose of study drug until end of the study (Up to week 15)
|
16.3%
7/43 • Number of events 10 • From first dose of study drug until end of the study (Up to week 15)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc
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