Trial Outcomes & Findings for A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause (NCT NCT04003155)

Last Updated: 2024-11-04

Results Overview

The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency 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 participant 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). Baseline was the average number of moderate to severe VMS per 24 hours based on the non-missing values in the 10 days immediately prior to randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

527 participants

Primary outcome timeframe

Baseline and week 4

Results posted on

2024-11-04

Participant Flow

Postmenopausal women participants 40 to 65 years of age who had moderate to severe vasomotor symptoms (VMS) and seeking treatment or relief for VMS associated with menopause, confirmed as menopausal, had to have minimum average of 7 to 8 moderate to severe hot flashes (HFs) (VMS) per day within the 10 days prior to randomization 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 10-day collection of baseline VMS frequency and severity assessments were performed.

Participant milestones

Participant milestones
Measure	Double-blind Period: Placebo Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg Participants received fezolinetant 30 mg (one 30 mg Fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Double-Blind (DB) Period (12 Weeks) STARTED	175	176	176	0	0
Double-Blind (DB) Period (12 Weeks) Full Analysis Set	175	173	174	0	0
Double-Blind (DB) Period (12 Weeks) Safety Analysis Set	175	174	173	0	0
Double-Blind (DB) Period (12 Weeks) Treated	175	173	174	0	0
Double-Blind (DB) Period (12 Weeks) COMPLETED	152	142	161	0	0
Double-Blind (DB) Period (12 Weeks) NOT COMPLETED	23	34	15	0	0
Extension Period (EP) (40 Weeks) STARTED	0	142	158	76	76
Extension Period (EP) (40 Weeks) COMPLETED	0	124	143	62	67
Extension Period (EP) (40 Weeks) NOT COMPLETED	0	18	15	14	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-blind Period: Placebo Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg Participants received fezolinetant 30 mg (one 30 mg Fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Double-Blind (DB) Period (12 Weeks) Adverse Event	9	8	5	0	0
Double-Blind (DB) Period (12 Weeks) Lost to Follow-up	3	4	0	0	0
Double-Blind (DB) Period (12 Weeks) Protocol Violation	1	3	3	0	0
Double-Blind (DB) Period (12 Weeks) Withdrawal by Subject	9	12	4	0	0
Double-Blind (DB) Period (12 Weeks) Miscellaneous	1	7	3	0	0
Extension Period (EP) (40 Weeks) Adverse Event	0	5	4	2	2
Extension Period (EP) (40 Weeks) Lost to Follow-up	0	1	3	1	1
Extension Period (EP) (40 Weeks) Withdrawal by Subject	0	12	7	9	5
Extension Period (EP) (40 Weeks) Miscellaneous	0	0	1	2	1

Baseline Characteristics

Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg n=176 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg n=176 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to week 52 during extension treatment period.	Total n=527 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 4.8 • n=175 Participants	54.1 Years STANDARD_DEVIATION 4.9 • n=176 Participants	54.3 Years STANDARD_DEVIATION 5.2 • n=176 Participants	54.4 Years STANDARD_DEVIATION 5.0 • n=527 Participants
Sex: Female, Male Female	175 Participants n=175 Participants	176 Participants n=176 Participants	176 Participants n=176 Participants	527 Participants n=527 Participants
Sex: Female, Male Male	0 Participants n=175 Participants	0 Participants n=176 Participants	0 Participants n=176 Participants	0 Participants n=527 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=175 Participants	43 Participants n=176 Participants	48 Participants n=176 Participants	137 Participants n=527 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=175 Participants	133 Participants n=176 Participants	128 Participants n=176 Participants	389 Participants n=527 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=175 Participants	0 Participants n=176 Participants	0 Participants n=176 Participants	1 Participants n=527 Participants
Race/Ethnicity, Customized Race: White	142 Participants n=175 Participants	150 Participants n=176 Participants	143 Participants n=176 Participants	435 Participants n=527 Participants
Race/Ethnicity, Customized Race: Black or African American	28 Participants n=175 Participants	21 Participants n=176 Participants	27 Participants n=176 Participants	76 Participants n=527 Participants
Race/Ethnicity, Customized Race: American Indian or Alaska Native	2 Participants n=175 Participants	0 Participants n=176 Participants	1 Participants n=176 Participants	3 Participants n=527 Participants
Race/Ethnicity, Customized Race: Asian	3 Participants n=175 Participants	3 Participants n=176 Participants	3 Participants n=176 Participants	9 Participants n=527 Participants
Race/Ethnicity, Customized Race: Pacific Islander	0 Participants n=175 Participants	0 Participants n=176 Participants	1 Participants n=176 Participants	1 Participants n=527 Participants
Race/Ethnicity, Customized Race: More Than One Race	0 Participants n=175 Participants	1 Participants n=176 Participants	1 Participants n=176 Participants	2 Participants n=527 Participants
Race/Ethnicity, Customized Race: Unknown	0 Participants n=175 Participants	1 Participants n=176 Participants	0 Participants n=176 Participants	1 Participants n=527 Participants
Frequency of Moderate and Severe Vasomotor Symptoms per 24 hours	10.51 VMS per day STANDARD_DEVIATION 3.79 • n=175 Participants • Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment.	10.65 VMS per day STANDARD_DEVIATION 4.73 • n=173 Participants • Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment.	10.44 VMS per day STANDARD_DEVIATION 3.92 • n=174 Participants • Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment.	10.53 VMS per day STANDARD_DEVIATION 4.16 • n=522 Participants • Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment.
Severity of Moderate and Severe Vasomotor Symptoms per 24 hours	2.43 Score on a scale STANDARD_DEVIATION 0.35 • n=175 Participants • FAS Population	2.39 Score on a scale STANDARD_DEVIATION 0.34 • n=173 Participants • FAS Population	2.40 Score on a scale STANDARD_DEVIATION 0.35 • n=174 Participants • FAS Population	2.41 Score on a scale STANDARD_DEVIATION 0.35 • n=522 Participants • FAS Population

PRIMARY outcome

Timeframe: Baseline and week 4

Population: Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment. Participants with available data at specified time point were included.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=166 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=157 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=164 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4	-3.32 VMS per day Standard Error 0.29	-5.19 VMS per day Standard Error 0.30	-5.39 VMS per day Standard Error 0.30	—	—

PRIMARY outcome

Timeframe: Baseline and week 12

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=139 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=131 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=146 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12	-3.90 VMS per day Standard Error 0.31	-6.28 VMS per day Standard Error 0.32	-6.44 VMS per day Standard Error 0.31	—	—

PRIMARY outcome

Timeframe: Baseline and week 4

Population: FAS population with available data at specified time point.

Severity of moderate to severe VMS per day at post baseline visit was calculated as follows: \[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/Total number of daily mild/moderate/severe hot flashes Moderate VMS was defined as sensation of heat with sweating/dampness, but participant 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 mild or moderate or severe VMS. Higher scores indicates greater severity.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=166 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=157 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=164 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4	-0.27 Score on a scale Standard Error 0.04	-0.42 Score on a scale Standard Error 0.04	-0.46 Score on a scale Standard Error 0.04	—	—

PRIMARY outcome

Timeframe: Baseline and week 12

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=139 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=131 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=146 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12	-0.37 Score on a scale Standard Error 0.05	-0.60 Score on a scale Standard Error 0.05	-0.57 Score on a scale Standard Error 0.05	—	—

SECONDARY outcome

Timeframe: Baseline and week 12

Population: FAS population with available data at specified time point.

The PROMIS SD SF 8b assesses self-reported sleep disturbance over the past 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Because it assesses the participants experience of sleep disturbance, the measure does not focus on specific sleep-disorder symptoms or ask patients to report objective measures of sleep (e.g., total amount of sleep, time to fall asleep and amount of wakefulness during sleep). Responses to each of the 8 items range from 1 (no disturbed sleep) to 5 (disturbed sleep), and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the disturbed sleep.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=148 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=133 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=156 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score at Week 12	-3.2 Score on a scale Standard Error 0.5	-3.7 Score on a scale Standard Error 0.6	-4.2 Score on a scale Standard Error 0.5	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=174 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=169 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=166 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 2	-2.76 VMS per day Standard Error 0.28	-4.73 VMS per day Standard Error 0.28	-4.58 VMS per day Standard Error 0.28	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 3	-3.15 VMS per day Standard Error 0.28	-5.14 VMS per day Standard Error 0.29	-5.25 VMS per day Standard Error 0.29	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 7	-3.71 VMS per day Standard Error 0.30	-5.80 VMS per day Standard Error 0.31	-5.97 VMS per day Standard Error 0.30	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 8	-3.71 VMS per day Standard Error 0.30	-6.10 VMS per day Standard Error 0.31	-6.10 VMS per day Standard Error 0.30	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 10	-4.09 VMS per day Standard Error 0.30	-6.30 VMS per day Standard Error 0.31	-6.25 VMS per day Standard Error 0.30	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 1	-1.82 VMS per day Standard Error 0.26	-3.63 VMS per day Standard Error 0.26	-3.07 VMS per day Standard Error 0.26	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 5	-3.49 VMS per day Standard Error 0.28	-5.56 VMS per day Standard Error 0.29	-5.67 VMS per day Standard Error 0.29	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 6	-3.58 VMS per day Standard Error 0.29	-5.70 VMS per day Standard Error 0.30	-5.97 VMS per day Standard Error 0.29	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 9	-4.09 VMS per day Standard Error 0.30	-6.16 VMS per day Standard Error 0.31	-6.24 VMS per day Standard Error 0.30	—	—
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 11	-3.89 VMS per day Standard Error 0.31	-6.37 VMS per day Standard Error 0.31	-6.34 VMS per day Standard Error 0.30	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=173 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=174 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 9	-0.35 Score on a scale Standard Error 0.05	-0.62 Score on a scale Standard Error 0.05	-0.56 Score on a scale Standard Error 0.05	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 11	-0.37 Score on a scale Standard Error 0.06	-0.64 Score on a scale Standard Error 0.06	-0.61 Score on a scale Standard Error 0.06	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 1	-0.15 Score on a scale Standard Error 0.03	-0.25 Score on a scale Standard Error 0.03	-0.25 Score on a scale Standard Error 0.03	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 2	-0.21 Score on a scale Standard Error 0.03	-0.35 Score on a scale Standard Error 0.04	-0.36 Score on a scale Standard Error 0.03	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 3	-0.27 Score on a scale Standard Error 0.04	-0.43 Score on a scale Standard Error 0.04	-0.43 Score on a scale Standard Error 0.04	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 5	-0.29 Score on a scale Standard Error 0.04	-0.46 Score on a scale Standard Error 0.04	-0.46 Score on a scale Standard Error 0.04	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 6	-0.30 Score on a scale Standard Error 0.05	-0.50 Score on a scale Standard Error 0.05	-0.55 Score on a scale Standard Error 0.05	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 7	-0.28 Score on a scale Standard Error 0.05	-0.52 Score on a scale Standard Error 0.05	-0.54 Score on a scale Standard Error 0.05	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 8	-0.29 Score on a scale Standard Error 0.05	-0.57 Score on a scale Standard Error 0.05	-0.53 Score on a scale Standard Error 0.05	—	—
Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 Week 10	-0.34 Score on a scale Standard Error 0.05	-0.62 Score on a scale Standard Error 0.05	-0.57 Score on a scale Standard Error 0.05	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=173 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=174 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 2	-25.08 Percent change Standard Error 2.50	-42.37 Percent change Standard Error 2.55	-43.37 Percent change Standard Error 2.54	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 3	-28.81 Percent change Standard Error 2.54	-46.94 Percent change Standard Error 2.59	-50.00 Percent change Standard Error 2.57	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 4	-30.59 Percent change Standard Error 2.67	-47.34 Percent change Standard Error 2.72	-51.65 Percent change Standard Error 2.69	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 5	-32.55 Percent change Standard Error 2.65	-50.12 Percent change Standard Error 2.71	-54.33 Percent change Standard Error 2.67	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 6	-33.35 Percent change Standard Error 2.72	-51.74 Percent change Standard Error 2.78	-57.18 Percent change Standard Error 2.73	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 7	-34.85 Percent change Standard Error 2.86	-53.14 Percent change Standard Error 2.93	-56.26 Percent change Standard Error 2.85	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 8	-35.71 Percent change Standard Error 2.83	-55.88 Percent change Standard Error 2.90	-56.89 Percent change Standard Error 2.83	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 11	-38.05 Percent change Standard Error 2.84	-58.37 Percent change Standard Error 2.90	-60.18 Percent change Standard Error 2.82	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 12	-37.06 Percent change Standard Error 2.89	-57.13 Percent change Standard Error 2.95	-61.24 Percent change Standard Error 2.86	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 1	-16.63 Percent change Standard Error 2.31	-32.15 Percent change Standard Error 2.34	-28.84 Percent change Standard Error 2.35	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 9	-39.64 Percent change Standard Error 2.87	-56.31 Percent change Standard Error 2.93	-58.54 Percent change Standard Error 2.85	—	—
Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 Week 10	-39.51 Percent change Standard Error 2.81	-57.39 Percent change Standard Error 2.87	-59.01 Percent change Standard Error 2.79	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: FAS Population

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=173 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=174 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 1	18 Participants	47 Participants	44 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 2	37 Participants	64 Participants	75 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 3	42 Participants	69 Participants	89 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 4	49 Participants	77 Participants	94 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 5	47 Participants	76 Participants	94 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 10	45 Participants	84 Participants	100 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 11	55 Participants	85 Participants	100 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 12	52 Participants	77 Participants	99 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 6	50 Participants	78 Participants	96 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 7	52 Participants	79 Participants	98 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 8	52 Participants	93 Participants	87 Participants	—	—
Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 9	56 Participants	85 Participants	97 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: FAS Population

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=173 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=174 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 2	1 Participants	3 Participants	4 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 3	1 Participants	6 Participants	5 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 6	2 Participants	8 Participants	10 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 8	2 Participants	10 Participants	14 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 9	5 Participants	15 Participants	16 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 10	7 Participants	17 Participants	18 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 11	10 Participants	16 Participants	19 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 12	6 Participants	12 Participants	18 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 1	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 4	5 Participants	6 Participants	8 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 5	2 Participants	10 Participants	6 Participants	—	—
Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 Week 7	2 Participants	13 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 48, 52 of fezolinetant exposure (weeks 16, 24, 28, 32, 36, 40, 44, 48 and 52 for arms Placebo/Fezolinetant 30 mg and Placebo/Fezolinetant 45 mg)

Population: FAS population with available data at specified time point.

The PGI is comprised of 2 companion 1-item PRO measures analogous to the Clinical Global Impression (CGI) scales. These measures provide brief, stand-alone global assessments prior to and after initiating a study medication. Patient-perceived change from the initiation of treatment (PGI-C)-VMS is used to evaluate meaningful within-person changes over time in VMS. This measure provides patient-perceived change from the initiation of treatment. The PGI-C VMS asks: "Compared to the beginning of this study, how would you rate your HFs/night sweats now?" Subject ratings range from (1) much better to (7) much worse. Participant ratings range from 1=much better, 2= moderately better, 3= a little better, 4= no change, 5= a little worse, 6= moderately worse, 7= much worse.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=160 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=150 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=160 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=68 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg n=70 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: Much better	32 Participants	50 Participants	72 Participants	—	1 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: A little better	44 Participants	42 Participants	35 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: No change	55 Participants	23 Participants	28 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: Moderately worse	1 Participants	1 Participants	1 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: Much better	35 Participants	50 Participants	74 Participants	31 Participants	44 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: Moderately better	24 Participants	24 Participants	30 Participants	14 Participants	16 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: No change	37 Participants	19 Participants	11 Participants	4 Participants	2 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: A little worse	6 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: Moderately worse	4 Participants	1 Participants	4 Participants	2 Participants	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: Much worse	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: Much better	—	1 Participants	2 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: Moderately better	—	2 Participants	1 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: No change	—	1 Participants	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: A little worse	—	0 Participants	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: Much worse	—	0 Participants	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: A little worse	—	0 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: Moderately worse	—	1 Participants	2 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: Much better	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: Moderately better	—	—	1 Participants	1 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: No change	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: Much worse	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: Much better	—	0 Participants	—	33 Participants	39 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: Moderately better	—	2 Participants	—	8 Participants	12 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: A little better	—	0 Participants	—	6 Participants	10 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: No change	—	0 Participants	—	6 Participants	1 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: Moderately worse	—	0 Participants	—	0 Participants	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: Moderately better	—	1 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: No change	—	0 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: A little worse	—	0 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: Much better	—	56 Participants	71 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: Moderately better	—	26 Participants	30 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: A little better	—	23 Participants	15 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: Moderately worse	—	0 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: Moderately better	21 Participants	33 Participants	24 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: A little worse	1 Participants	1 Participants	0 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 4: Much worse	6 Participants	0 Participants	0 Participants	—	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 12: A little better	40 Participants	41 Participants	35 Participants	16 Participants	8 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: A little better	—	1 Participants	1 Participants	1 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 16: Moderately worse	—	0 Participants	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: Much better	—	1 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: Moderately better	—	1 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: A little better	—	0 Participants	2 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: No change	—	1 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: A little worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: Moderately worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 20: Much worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: Much better	—	55 Participants	81 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: Moderately better	—	27 Participants	30 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: A little better	—	34 Participants	27 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: No change	—	10 Participants	6 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 24: Much worse	—	0 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: Much better	—	0 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: Moderately better	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: A little better	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: No change	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: A little worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: Moderately worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 28: Much worse	—	0 Participants	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: Moderately better	—	—	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: A little better	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: No change	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: A little worse	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: Moderately worse	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 32: Much worse	—	—	0 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: Much better	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: A little better	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: A little worse	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 36: Moderately worse	—	—	0 Participants	0 Participants	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: A little worse	—	0 Participants	—	2 Participants	1 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 40: Much worse	—	0 Participants	—	0 Participants	0 Participants
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: Much better	—	0 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: A little better	—	1 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: Moderately worse	—	0 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 48: Much worse	—	0 Participants	—	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: No change	—	6 Participants	8 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: A little worse	—	0 Participants	1 Participants	—	—
Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit Week 52: Much worse	—	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetanat 30 mg and Placebo/Fezolinetant 45 mg)

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=121 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=138 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=60 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=62 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Frequency of Moderate, and Severe VMS at Week 24	-7.15 VMS per day Standard Deviation 6.02	-7.32 VMS per day Standard Deviation 4.58	-6.89 VMS per day Standard Deviation 3.67	-7.32 VMS per day Standard Deviation 4.53	—

SECONDARY outcome

Timeframe: Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetanat 30 mg and Placebo/Fezolinetant 45 mg)

Population: FAS population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=121 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=138 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=60 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=62 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Change From Baseline in The Mean Severity of Moderate, and Severe VMS at Week 24	-0.75 Score on a scale Standard Deviation 0.82	-0.77 Score on a scale Standard Deviation 0.90	-0.78 Score on a scale Standard Deviation 0.80	-0.76 Score on a scale Standard Deviation 0.89	—

SECONDARY outcome

Timeframe: From first dose date up to 21 days after last dose (to 55 weeks)

Population: Safety population included all randomized participants who took at least 1 dose of study intervention. A participant erroneously receiving a treatment different from their randomized treatment was assigned to the treatment group that the participant received as first dose.

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 inpatient 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 21 days after last dose.

Outcome measures

Outcome measures
Measure	Double-blind Period: Placebo n=175 Participants Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg n=174 Participants Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment.	Double-blind Period: Fezolinetant 45 mg n=173 Participants Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=76 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg n=76 Participants Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Number of Participants With Adverse Events Drug-Related TEAE	22 Participants	20 Participants	21 Participants	6 Participants	2 Participants
Number of Participants With Adverse Events Serious TEAE	1 Participants	7 Participants	8 Participants	3 Participants	2 Participants
Number of Participants With Adverse Events Drug-Related Serious TEAE	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events TEAE Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Drug-Related TEAE Leading to Withdrawal of Treatment	7 Participants	7 Participants	5 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events TEAE	78 Participants	108 Participants	115 Participants	48 Participants	37 Participants
Number of Participants With Adverse Events Drug-Related TEAE Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events TEAE Leading to Withdrawal of Treatment	9 Participants	13 Participants	8 Participants	2 Participants	1 Participants

Adverse Events

Double-blind Period: Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg

Serious events: 8 serious events

Other events: 45 other events

Deaths: 0 deaths

Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double-blind Period: Placebo n=175 participants at risk Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg n=174 participants at risk Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.	Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg n=173 participants at risk Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=76 participants at risk Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg n=76 participants at risk Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
General disorders Chest pain	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Hepatobiliary disorders Cholelithiasis	0.57% 1/175 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Infections and infestations COVID-19 pneumonia	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Injury, poisoning and procedural complications Foot fracture	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Blood pressure increased	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Liver function test increased	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Transaminases increased	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Apocrine breast carcinoma	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Nervous system disorders Paraesthesia	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Psychiatric disorders Anxiety	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Renal and urinary disorders Renal colic	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Renal and urinary disorders Ureteric stenosis	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Reproductive system and breast disorders Pelvic pain	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.57% 1/174 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/173 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Vascular disorders Varicose vein	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/174 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.58% 1/173 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)

Other adverse events

Other adverse events
Measure	Double-blind Period: Placebo n=175 participants at risk Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD up to week 12 during double-blind treatment period.	Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg n=174 participants at risk Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.	Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg n=173 participants at risk Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg n=76 participants at risk Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.	Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg n=76 participants at risk Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Infections and infestations COVID-19	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.2% 9/174 • Number of events 9 • From first dose date up to 21 days after last dose (up to 55 weeks)	6.4% 11/173 • Number of events 11 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.3% 4/76 • Number of events 4 • From first dose date up to 21 days after last dose (up to 55 weeks)	7.9% 6/76 • Number of events 6 • From first dose date up to 21 days after last dose (up to 55 weeks)
Infections and infestations Urinary tract infection	1.7% 3/175 • Number of events 3 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.7% 3/174 • Number of events 6 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.2% 9/173 • Number of events 9 • From first dose date up to 21 days after last dose (up to 55 weeks)	2.6% 2/76 • Number of events 2 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 2 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Alanine aminotransferase increased	2.3% 4/175 • Number of events 4 • From first dose date up to 21 days after last dose (up to 55 weeks)	4.6% 8/174 • Number of events 9 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.8% 10/173 • Number of events 13 • From first dose date up to 21 days after last dose (up to 55 weeks)	2.6% 2/76 • Number of events 2 • From first dose date up to 21 days after last dose (up to 55 weeks)	2.6% 2/76 • Number of events 2 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Blood alkaline phosphatase increased	3.4% 6/175 • Number of events 6 • From first dose date up to 21 days after last dose (up to 55 weeks)	3.4% 6/174 • Number of events 6 • From first dose date up to 21 days after last dose (up to 55 weeks)	2.9% 5/173 • Number of events 8 • From first dose date up to 21 days after last dose (up to 55 weeks)	6.6% 5/76 • Number of events 11 • From first dose date up to 21 days after last dose (up to 55 weeks)	1.3% 1/76 • Number of events 1 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Blood glucose increased	0.00% 0/175 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.7% 10/174 • Number of events 15 • From first dose date up to 21 days after last dose (up to 55 weeks)	4.6% 8/173 • Number of events 14 • From first dose date up to 21 days after last dose (up to 55 weeks)	2.6% 2/76 • Number of events 4 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Investigations Gamma-glutamyltransferase increased	2.3% 4/175 • Number of events 4 • From first dose date up to 21 days after last dose (up to 55 weeks)	3.4% 6/174 • Number of events 8 • From first dose date up to 21 days after last dose (up to 55 weeks)	4.0% 7/173 • Number of events 12 • From first dose date up to 21 days after last dose (up to 55 weeks)	5.3% 4/76 • Number of events 4 • From first dose date up to 21 days after last dose (up to 55 weeks)	0.00% 0/76 • From first dose date up to 21 days after last dose (up to 55 weeks)
Nervous system disorders Headache	7.4% 13/175 • Number of events 14 • From first dose date up to 21 days after last dose (up to 55 weeks)	6.3% 11/174 • Number of events 17 • From first dose date up to 21 days after last dose (up to 55 weeks)	8.1% 14/173 • Number of events 15 • From first dose date up to 21 days after last dose (up to 55 weeks)	3.9% 3/76 • Number of events 5 • From first dose date up to 21 days after last dose (up to 55 weeks)	6.6% 5/76 • Number of events 11 • From first dose date up to 21 days after last dose (up to 55 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