Trial · NCT06440967
Registered outcomes59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 59
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS | Baseline to Week 4 | Frequency of moderate and severe vasomotor symptoms (VMS) events will be calculated as the sum of moderate and severe VMS events per day. |
| Primary | Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS | Baseline to Week 12 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Primary | Mean change from Baseline to Week 4 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 to Week 12 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 Week 12 in the MENQOL VMS 1 week recall domain score | Baseline to Week 12 | The Menopause-specific Quality of Life Questionnaire (MENQOL) is a 29-item patient-reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: 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 overall questionnaire 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 in MENQoL. |
| Secondary | Mean Change from Baseline to Week 12 in the PROMIS SD SF 8b Total (raw) Score | Baseline to Week 12 | The Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (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 | Mean change from Baseline to Week 24 in the frequency of moderate to severe VMS | Baseline to Week 24 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Secondary | Mean Change from Baseline to Week 24 in the severity of moderate to severe VMS | Baseline to Week 24 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to Week 55 | A TEAE is defined as Adverse Event (AE) observed after starting administration of the investigational study intervention and up to 21 days after the last dose of investigational study intervention. |
| Secondary | Number of participants with Adverse Events of Special Interest (AESIs) | Up to Week 55 | AEs of special interest in this study will include: Progression of breast cancer including metastasis; Adverse events of uterine bleeding; Adverse events of liver test elevations; Any liver AE leading to discontinuation. |
| Secondary | Number of participants with laboratory value abnormalities and/or adverse events (AEs) | Up to Week 55 | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of participants with vital sign abnormalities and/or adverse events (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 Adverse Events (AEs) | Up to Week 52 | Number of participants with potentially clinically significant ECG values. |
| Secondary | Mean change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 1 to 3 | Baseline and Weeks 1 to 3 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Secondary | Mean Change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 5 to 11 | Baseline and Weeks 5 to 11 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Secondary | Mean change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 1 to 3 | Baseline and Weeks 1 to 3 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean Change from Baseline in the severity of moderate to severe VMS to the average severity of moderate to severe VMS over weeks 5 to 11 | Baseline and Weeks 5 to 11 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Percent reduction >/= 50% in the frequency of moderate and severe VMS from baseline | Baseline to Weeks 1, 4, 8 and 12 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of \>/= 50% will be reported. |
| Secondary | Percent reduction >/= 75% in the frequency of moderate and severe VMS from baseline | Baseline to Weeks 1, 4, 8 and 12 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of \>/= 75% will be reported. |
| Secondary | Percent reduction at 100% in the frequency of moderate and severe VMS from baseline | Baseline to Weeks 1, 4, 8 and 12 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of 100% will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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