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Trial · NCT02253173

Registered outcomes48

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCo-Primary Efficacy Endpoint - Vaginal Superficial CellsBaseline and 12 Weeks• Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo
PrimaryCo-Primary Efficacy Endpoint - Vaginal Parabasal CellsBaseline and 12 Weeks• Change from Baseline to Week 12 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo
PrimaryCo-Primary Efficacy Endpoint - Vaginal pHBaseline and 12 Weeks• Change from Baseline to Week 12 in vaginal pH as compared to placebo
PrimaryCo-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)Baseline and Week 12
• Change from Baseline to Week 12 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 12
SecondarySecondary Efficacy Endpoints - Vaginal Superficial CellsBaseline and Week 2• Change from Baseline to Week 2 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints- Vaginal Superficial CellsBaseline and Week 6Change from Baseline to Week 6 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal Superficial CellsBaseline and Week 8Change from Baseline to Week 8 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal Parabasal CellsBaseline and Week 2Change from Baseline to Week 2 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal Parabasal CellsBaseline and Week 6Change from Baseline to Week 6 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal Parabasal CellsBaseline and Week 8Change from Baseline to Week 8 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal pHBaseline and Week 2Change from Baseline to Week 2 in vaginal pH as compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal pHBaseline and Week 6Change from Baseline to Week 6 in vaginal pH as compared to placebo
SecondarySecondary Efficacy Endpoints - Vaginal pHBaseline and Week 8Change from Baseline to Week 8 in vaginal pH as compared to placebo
SecondarySecondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)Baseline and Week 2
Change from Baseline to Week 2 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 2
SecondarySecondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)Baseline and Week 6
Change from Baseline to Week 6 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 6
SecondarySecondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)Baseline and Week 8
Change from Baseline to Week 8 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 8
SecondarySecondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)Baseline and Week 2
Change from Baseline to Week 2 on the severity of vaginal dryness associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 2
SecondarySecondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)Baseline and Week 6
Change from Baseline to Week 6 on the severity of vaginal dryness associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 6
SecondarySecondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)Baseline and Week 8
Change from Baseline to Week 8 on the severity of vaginal dryness associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 8
SecondarySecondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)Baseline and Week 12
Change from Baseline to Week 12 on the severity of vaginal dryness associated with VVA as compared to placebo VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Subjects assessed severity at Baseline and Week 12

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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