Trial · NCT07455812
A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
NCT07455812, Completed, Astellas Pharma Europe Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause. Trials, record NCT07455812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07455812
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
- NCT number
- NCT07455812
- Status
- Completed
- Enrollment
- 105 participants, actual
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Conditions
- Hot Flashes
- Interventions
- Fezolinetant
- First posted
- 2026-03-06
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants reporting improvement in hot flushes/night sweats measured by Patient Global Impression of Change of VMS (PGI-C VMS) | Week 24 | The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement. |
| Secondary | Percentage of participants reporting improvement in hot flushes/night sweats measured by PGI-C VMS | Up to Week 12 | The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement. |
| Secondary | Change from baseline in VMS in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall Vasomotor domain score | Baseline, Week 12 and Week 24 | The MENQoL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26) and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to 6 (extremely bothersome) scale. |
| Secondary | Chage from baseline in menopause-related quality of life (MENQoL) total score | Baseline, Week 12 and Week 24 | The MENQoL is a 29-item PRO measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26) and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to 6 (extremely bothersome) scale. |
| Secondary | Change from baseline in sleep disturbance measured by Patient Global Impression of Change of Sleep Disturbance (PGI-C SD) | Baseline, Week 1, Week 12 and Week 24 | PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Participant ratings range from (1) much better to (7) much worse. |
| Secondary | Change from baseline in total score of Patient-Reported Outcomes Measurement Information System, Sleep Disturbance - Short Form (PROMIS SD SF) 8b | Baseline, Week 12 and Week 24 | 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. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep). |
| Secondary | Treatment satisfaction | Up to Week 24 | Treatment satisfaction will be assessed using 1 question that will be created for this study. |
| Secondary | Number of participants who discontinue fezolinetant | Up to Week 24 | |
| Secondary | Reasons for discontinuing fezolinetant (including potential switching patterns) | Up to Week 24 | |
| Secondary | Number of participants with Adverse Events (AEs) | Up to Week 24 | An adverse event is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have a causal relationship with this treatment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
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/NCT07455812
GET https://conductscience.org/api/trials/v1/NCT07455812/registered