Trial · NCT02253173
Outcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 48
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal Superficial Cells | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Vaginal pH | Baseline and 12 Weeks | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | pH units | LEAST_SQUARES_MEAN |
| PRIMARY | Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 12 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints- Vaginal Superficial Cells | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Superficial Cells | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal superficial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal Parabasal Cells | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | percentage of vaginal parabasal cells | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal pH | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | pH units | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal pH | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | pH units | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Vaginal pH | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | pH units | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia) | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness) | Baseline and Week 2 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness) | Baseline and Week 6 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness) | Baseline and Week 8 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness) | Baseline and Week 12 | For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline. | units on a scale | LEAST_SQUARES_MEAN |
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.
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