Clinical Trial: DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

Brief Summary: The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Detailed Summary:
Sponsor: EndoCeutics Inc.

Current Primary Outcome:

  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal Cell Maturation (Percentage of Parabasal Cells). [ Time Frame: 12 weeks ]

    Decrease in Percentage of Parabasal Cells:

    The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types.

  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal Cell Maturation (Percentage of Superficial Cells). [ Time Frame: 12 weeks ]

    Increase in % of Superficial Cells:

    The percentage of superficial cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types.

  • Co-primary Endpoint: Change From Baseline Over Time of Vaginal pH. [ Time Frame: 12 weeks ]

    Decrease of vaginal pH:

    A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded.

  • Co-primary Endpoint: Change From

    Original Primary Outcome:

    • Co-primary endpoint: change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). [ Time Frame: 12 weeks ]
    • Co-primary Endpoint: Change From Baseline Over Time of Vaginal pH. [ Time Frame: 12 weeks ]
    • Co-primary endpoint: change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. [ Time Frame: 12 weeks ]


    Current Secondary Outcome:

    • Change From Baseline Over Time of Self-assessment of Vaginal Dryness. [ Time Frame: 12 weeks ]

      Decrease in the severity of vaginal dryness:

      The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using score values of 0, 1, 2 or 3, respectively.

    • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Secretions) [ Time Frame: 12 weeks ]

      Improvement of vaginal secretions:

      To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were then analyzed using the score values of 1, 2, 3 and 4, respectively.

    • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Epithelial Integrity) [ Time Frame: 12 weeks ]

      Improvement of the vaginal epithelial integrity:

      To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively.

    • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Epithelial Surface Thickness) [ Time Frame: 12 weeks ]

      Improvement of the vaginal epithelial surface thickness:

      To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively.

    • Local Tolerance to Intravaginal Administration of DHEA (Vaginal Color) [ Time Frame: 12 weeks ]

      Improvement of the vaginal color:

      To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the values of 1, 2, 3 and 4, respectively.



    Original Secondary Outcome: Local tolerance to intravaginal administration of DHEA. [ Time Frame: 12 weeks ]

    Information By: EndoCeutics Inc.

    Dates:
    Date Received: December 3, 2010
    Date Started: December 2010
    Date Completion:
    Last Updated: March 14, 2017
    Last Verified: March 2017