Trial · NCT04003155
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
NCT04003155, Phase 3, Completed, Astellas Pharma Global Development, Inc.; results first posted 2022-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause. Trials, record NCT04003155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04003155
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
- NCT number
- NCT04003155
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 527 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Hot Flashes
- Interventions
- fezolinetant, placebo
- First posted
- 2019-07-01
- Last updated
- 2024-11-04
- Other registries' IDs
- eudract:2018-003528-35
- Results first posted
- 2022-08-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Baseline and week 4 | 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. |
| Primary | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Baseline and week 12 | 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. |
| Primary | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Baseline and week 4 | 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. |
| Primary | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Baseline and week 12 | 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. |
| Secondary | 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 | Baseline and week 12 | 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. |
| Secondary | Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | 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. |
| Secondary | Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | 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. |
| Secondary | Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 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. |
| Secondary | 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 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 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. Participant has \>=50% reduction from baseline to each post baseline week for the frequency of moderate to severe VMS. |
| Secondary | 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 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 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. Participant has 100% reduction from baseline to each post baseline week for the frequency of moderate to severe VMS. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Baseline and week 4 | 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. | VMS per day | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Baseline and week 12 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Baseline and week 4 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Baseline and week 12 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and week 12 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS population with available data at specified time point. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS Population | Participants | NUMBER |
| SECONDARY | 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 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS Population | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group425
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Double-blind Period: Placebo | -3.32 | Standard Error 0.29 | VMS per day | |
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Double-blind Period: Fezolinetant 30 mg | -5.19 | Standard Error 0.30 | VMS per day | |
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Double-blind Period: Fezolinetant 45 mg | -5.39 | Standard Error 0.30 | VMS per day | |
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Double-blind Period: Placebo | -3.90 | Standard Error 0.31 | VMS per day | |
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Double-blind Period: Fezolinetant 30 mg | -6.28 | Standard Error 0.32 | VMS per day | |
| Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Double-blind Period: Fezolinetant 45 mg | -6.44 | Standard Error 0.31 | VMS per day | |
| Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Double-blind Period: Placebo | -0.27 | Standard Error 0.04 | Score on a scale | |
| Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Double-blind Period: Fezolinetant 30 mg | -0.42 | Standard Error 0.04 | Score on a scale | |
| Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Double-blind Period: Fezolinetant 45 mg | -0.46 | Standard Error 0.04 | Score on a scale | |
| Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Double-blind Period: Placebo | -0.37 | Standard Error 0.05 | Score on a scale |
1 to 10 of 425Source ClinicalTrials.gov
See all 425 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (DB) Period (12 Weeks) | STARTED | Double-blind Period: Placebo | 175 | |
| Double-Blind (DB) Period (12 Weeks) | STARTED | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 176 | |
| Double-Blind (DB) Period (12 Weeks) | STARTED | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 176 | |
| Double-Blind (DB) Period (12 Weeks) | STARTED | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 0 | |
| Double-Blind (DB) Period (12 Weeks) | STARTED | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 0 | |
| Double-Blind (DB) Period (12 Weeks) | Full Analysis Set | Double-blind Period: Placebo | 175 | |
| Double-Blind (DB) Period (12 Weeks) | Full Analysis Set | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 173 | |
| Double-Blind (DB) Period (12 Weeks) | Full Analysis Set | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 174 | |
| Double-Blind (DB) Period (12 Weeks) | Full Analysis Set | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 0 | |
| Double-Blind (DB) Period (12 Weeks) | Full Analysis Set | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events145
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Double-blind Period: Placebo | 0 | 175 | 0 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 9 | 174 | 9 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 11 | 173 | 11 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 4 | 76 | 4 |
| other | COVID-19 | Infections and infestations | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 6 | 76 | 6 |
| other | Urinary tract infection | Infections and infestations | Double-blind Period: Placebo | 3 | 175 | 3 |
| other | Urinary tract infection | Infections and infestations | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 3 | 174 | 6 |
| other | Urinary tract infection | Infections and infestations | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 9 | 173 | 9 |
| other | Urinary tract infection | Infections and infestations | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 2 | 76 | 2 |
| other | Urinary tract infection | Infections and infestations | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 1 | 76 | 2 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Period: Placebo | 0 | 175 |
| Total, all-cause mortality | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 0 | 174 |
| Total, all-cause mortality | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 0 | 173 |
| Total, all-cause mortality | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 0 | 76 |
| Total, all-cause mortality | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 0 | 76 |
| Total, other adverse events | Double-blind Period: Placebo | 24 | 175 |
| Total, other adverse events | Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg | 38 | 174 |
| Total, other adverse events | Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg | 45 | 173 |
| Total, other adverse events | Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg | 18 | 76 |
| Total, other adverse events | Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg | 14 | 76 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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