Trial · NCT06049797
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| 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. |
| Secondary | Change from baseline in average daily sleep latency, 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 | Mean change from baseline in the MENQoL total score | Baseline to weeks 4, 8, 12, 24 and 52 | 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. The total score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference for the MENQoL. |
| Secondary | Mean change from baseline in the MENQoL vasomotor 1-week recall VMS domain score | Baseline to weeks 4, 8, 24 and 52 | 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 | Mean change from baseline in the MENQoL 1-week recall psychosocial domain score | Baseline to weeks 4, 8, 12, 24 and 52 | 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 | Mean change from baseline in the MENQoL 1-week recall physical domain score | Baseline to weeks 4, 8, 12, 24 and 52 | 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 | Mean change from baseline in the MENQoL 1-week recall sexual domain score | Baseline to weeks 4, 8, 12, 24 and 52 | 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 | Total score from PGI-C VMS | Up to week 52 | PGI-C VMS evaluates participant perceived change in VMS. Ratings range from (1) much better to (7) much worse. |
| Secondary | Mean change from baseline in the VMS-related work productivity and activity impairment (WPAI-VMS) domain score | Baseline to weeks 4, 8, 12, 24 and 52 | The WPAI-VMS is a 6-item PRO measure that examines VMS-related work productivity and activity in the preceding 7 days. It consists of 4 domains: absenteeism, presenteeism, overall work productivity loss, and activity impairment. WPAI-VMS outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (that is, worse outcomes). |
| Secondary | Mean change from baseline in the female sexual function index (FSFI) domain score | Baseline to weeks 4, 8, 12, 24 and 52 | The FSFI is comprised of 19 questions with response options varying among items and ranging from 0 to 5 or 1 to 5. The FSFI has 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Within the individual domains, a domain score of zero indicates that the participant-reported having no sexual activity during the past month. The overall score can range from 2 to 36. A higher score overall or for individual domains indicates better sexual function. |
| Secondary | Mean change from baseline in the mean number of moderate/severe VMS episodes per 24 hours self-reported by participants via an an eDiary | Baseline to weeks 4, 8 and 12 | Participant manually records moderate/severe VMS episodes on the eDiary. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
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GET https://conductscience.org/api/trials/v1/NCT06049797/registered