Trial · NCT04234204
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
NCT04234204, Phase 3, Completed, Astellas Pharma China, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause. Trials, record NCT04234204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04234204
On this page
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 in Asia Going Through Menopause
- NCT number
- NCT04234204
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- Astellas Pharma China, Inc.
- Conditions
- Hot Flashes
- Interventions
- Fezolinetant, Placebo
- First posted
- 2020-01-21
- Last updated
- 2025-01-31
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS) | Baseline to Week 4 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Primary | Mean change from baseline in the frequency of moderate to severe VMS | Baseline to Week 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Primary | Mean change from baseline in the severity of moderate to severe VMS | Baseline to Week 4 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Primary | Mean change from baseline in the severity of moderate to severe VMS | Baseline to Week 12 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean change from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Mean change from baseline to each week in the severity of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean percent reduction from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Percent reduction ≥50% from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥50% reduction in frequency will be reported. |
| Secondary | Percent reduction at 100% from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥ 100% reduction in frequency will be reported. |
| Secondary | Mean change from baseline in the frequency of moderate to severe VMS | Baseline to Week 24 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38818888 | 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/NCT04234204
GET https://conductscience.org/api/trials/v1/NCT04234204/registered?page=2