Trial · NCT06049797
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
NCT06049797, Completed, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats. Trials, record NCT06049797. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06049797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
- NCT number
- NCT06049797
- Status
- Completed
- Enrollment
- 999 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Hot Flashes
- Interventions
Fezolinetant, Paroxetine, Citalopram, Escitalopram, Desvenlafaxine, Venlafaxine, Gabapentin, Clonidine, Pregabalin, Oxybutynin, Any other SSRI/SNRI not already specified, Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above
- First posted
- 2023-09-22
- Last updated
- 2026-06-05
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 to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score | Baseline and week 12 | The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL. |
| Secondary | Percentage of participants classified as 1-point responders as measured by the MENQol 1-week recall VMS domain | Up to week 52 | Participants with a reduction (improvement) in symptom bother score ≥ 1 unit will be classified as 1-point responders. |
| Secondary | Percentage of participants classified as 2-point responders as measured by the MENQol 1-week recall VMS domain | Up to week 52 | Participants with a reduction (improvement) in symptom bother score ≥ 2 unit will be classified as 2-point responders. |
| Secondary | Mean change from baseline in total score of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Sexual Function (PROMIS SD SF) 8b | Baseline and weeks 4, 8, 12, 24 and 52 | 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 | Total score from Patient Global Impression of Severity (PGI-S) of SD | Up to week 52 | The PGI-S SD evaluates patient perceived severity of sleep disturbance. Ratings range from (1) no problems to (4) severe problems. |
| Secondary | Total score from Patient Global Impression of Change (PGI-C) of SD | Up to week 52 | PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse. |
| Secondary | Change from baseline in average daily total sleep time, as recorded by wearable device | Baseline to weeks 4, 8 and 12 | The wearable device will capture movement and physiological signals to derive measures related to sleep. |
| Secondary | Change from baseline in average daily sleep efficiency, as recorded by wearable device | Baseline to weeks 4, 8 and 12 | The wearable device will capture movement and physiological signals to derive measures related to sleep. |
| Secondary | Change from baseline in average daily wake after sleep onset (WASO), as recorded by wearable device | Baseline to weeks 4, 8 and 12 | The wearable device will capture movement and physiological signals to derive measures related to sleep. |
| Secondary | Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device | Baseline to weeks 4, 8 and 12 | The wearable device will capture movement and physiological signals to derive measures related to sleep. |
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.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06049797
GET https://conductscience.org/api/trials/v1/NCT06049797/registered?page=2