Trial · NCT06206421
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
NCT06206421, Phase 3, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause. Trials, record NCT06206421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06206421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
- NCT number
- NCT06206421
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 277 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Hot Flashes
- Interventions
- Fezolinetant, Placebo
- First posted
- 2024-01-16
- Last updated
- 2026-04-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Adverse Events (AEs) | Up to Week 55 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. |
| Secondary | Change from baseline in endometrial thickness in post-menopausal participants | Baseline and up to Week 52 | Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU). |
| Secondary | Number of participants with laboratory value abnormalities and/or AEs | Up to Week 55 | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of participants with vital sign abnormalities and/or AEs | Up to Week 55 | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities and/or AEs | Up to Week 52 | Number of participants with potentially clinically significant ECG values. |
| Secondary | Pharmacokinetics (PK) of fezolinetant in plasma: Concentration | Up to Week 52 | Concentration will be recorded from the PK plasma samples collected. |
| Secondary | Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration | Up to Week 52 | Concentration will be recorded from the PK plasma samples collected. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06206421
GET https://conductscience.org/api/trials/v1/NCT06206421/registered