Trial · NCT03192176
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
NCT03192176, Phase 2, Completed, Astellas Pharma Global Development, Inc.; results first posted 2021-09-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes). Trials, record NCT03192176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03192176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
- NCT number
- NCT03192176
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 356 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Menopause, Hot Flashes
- Interventions
- Fezolinetant, Placebo
- First posted
- 2017-06-19
- Last updated
- 2024-11-26
- Results first posted
- 2021-09-29
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (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 and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). |
| Primary | Co-Primary Efficacy Endpoint: 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 and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). |
| Primary | Co-Primary Efficacy Endpoint: 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 was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. |
| Primary | Co-Primary Efficacy Endpoint: 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 was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity. |
| Secondary | Change From Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). |
| Secondary | Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 | The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). |
| Secondary | Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Severity of mild, moderate \& severe VMS per day was calculated as follows \[(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily mild/moderate/severe VMS Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot \& was sweating \& needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity. |
| Secondary | Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 | Severity of moderate to severe VMS per day was calculated as follows: \[(number of moderate VMS × 2) + (number of severe VMS × 3)\]/number of daily moderate/severe VMS. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity. |
| Secondary | Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: (number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3). Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity. |
| Secondary | Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | The hot flash score per 24h of moderate and severe VMS is calculated as follows: (number of moderate VMS x 2) + (number of severe VMS x 3). Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Baseline and week 4 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint: 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 | Co-Primary Efficacy Endpoint: 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 | Co-Primary Efficacy Endpoint: 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 Frequency of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14 and 15 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group3,392
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Placebo BID | -4.2 | Standard Error 0.65 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 15 mg BID | -6.1 | Standard Error 0.65 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 30 mg BID | -7.2 | Standard Error 0.64 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 60 mg BID | -7.0 | Standard Error 0.62 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 90 mg BID | -7.7 | Standard Error 0.65 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 30 mg QD | -6.5 | Standard Error 0.65 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 60 mg QD | -7.2 | Standard Error 0.61 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 | Fezolinetant 120 mg QD | -6.6 | Standard Error 0.63 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Placebo | -5.3 | Standard Error 0.58 | VMS per day | |
| Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Fezolinetant 15 mg BID | -7.2 | Standard Error 0.54 | VMS per day |
1 to 10 of 3,392Source ClinicalTrials.gov
See all 3,392 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo BID | 44 | |
| Overall Study | STARTED | Fezolinetant 15 mg BID | 45 | |
| Overall Study | STARTED | Fezolinetant 30 mg BID | 44 | |
| Overall Study | STARTED | Fezolinetant 60 mg BID | 45 | |
| Overall Study | STARTED | Fezolinetant 90 mg BID | 44 | |
| Overall Study | STARTED | Fezolinetant 30 mg QD | 45 | |
| Overall Study | STARTED | Fezolinetant 60 mg QD | 45 | |
| Overall Study | STARTED | Fezolinetant 120 mg QD | 44 | |
| Overall Study | Treated | Placebo BID | 43 | |
| Overall Study | Treated | Fezolinetant 15 mg BID | 45 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events80
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 | Diarrhoea | Gastrointestinal disorders | Placebo BID | 1 | 43 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 15 mg BID | 0 | 45 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 30 mg BID | 1 | 43 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 60 mg BID | 2 | 45 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 90 mg BID | 2 | 44 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 30 mg QD | 1 | 43 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 60 mg QD | 3 | 45 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Fezolinetant 120 mg QD | 0 | 44 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo BID | 1 | 43 | 1 |
| other | Nausea | Gastrointestinal disorders | Fezolinetant 15 mg BID | 1 | 45 | 1 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo BID | 0 | 43 |
| Total, all-cause mortality | Fezolinetant 15 mg BID | 0 | 45 |
| Total, all-cause mortality | Fezolinetant 30 mg BID | 0 | 43 |
| Total, all-cause mortality | Fezolinetant 60 mg BID | 0 | 45 |
| Total, all-cause mortality | Fezolinetant 90 mg BID | 0 | 44 |
| Total, all-cause mortality | Fezolinetant 30 mg QD | 0 | 43 |
| Total, all-cause mortality | Fezolinetant 60 mg QD | 0 | 45 |
| Total, all-cause mortality | Fezolinetant 120 mg QD | 0 | 44 |
| Total, other adverse events | Placebo BID | 5 | 43 |
| Total, other adverse events | Fezolinetant 15 mg BID | 9 | 45 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32102086 | DERIVED |
Source PubMed
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03192176
GET https://conductscience.org/api/trials/v1/NCT03192176/registered?page=2