Clinical Trial: Topical DHEA Against Vaginal Atrophy

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

Official Title: Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

Brief Summary: The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from 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 % of Parabasal Cells:

  The percentage of parabasal cells 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 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 cells 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 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 was applied directly to the lateral wall of the vagina using forceps. 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 Baseline Over Time of Self-assessment of th
  
  

  Original Primary Outcome:

  • Co-primary endpoint: change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells; maturation value) [ 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 in the moderate to severe symptom of vaginal atrophy identified by the subject as most bothersome to her. [ Time Frame: 12 weeks ]
  
  
  

  Current Secondary Outcome:

  • Change From Baseline Over Time of Vaginal Secretions [ Time Frame: 12 weeks ]

    Improvement of vaginal secretions:

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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 analyzed using the score values of 1, 2, 3 and 4, respectively.

  • Change From Baseline Over Time of Vaginal Epithelial Integrity [ Time Frame: 12 weeks ]

    Improvement of Vaginal Epithelial Integrity:

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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 analyzed using the score values of 1, 2, 3 and 4, respectively.

  • Change From Baseline Over Time of Vaginal Epithelial Surface Thickness [ Time Frame: 12 weeks ]

    Improvement of Vaginal Epithelial Surface Thickness:

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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 analyzed using the score values of 1, 2, 3 and 4, respectively.

  • Change From Baseline Over Time of Vaginal Color [ Time Frame: 12 weeks ]

    Improvement of Vaginal Color:

    To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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 analyzed using the score values of 1, 2, 3 and 4, respectively.

  
  
  

  Original Secondary Outcome:

  • Local tolerance to intravaginal administration of DHEA. [ Time Frame: 12 weeks ]
  • Change from baseline over time in quality of life evaluated by the Menopause Specific Quality of Life (MENQOL) questionnaire. [ Time Frame: 12 weeks ]
  • Change from baseline over time in sexual function evaluated by the Abbreviated Sexual Function (ASF), the Sexual Concern (SC) and the Psychological General Well-Being (PGWB) questionnaires. [ Time Frame: 12 weeks ]
  
  
  Information By: EndoCeutics Inc.
  

  Dates:
  Date Received: May 1, 2013
  Date Started: June 2007
  Date Completion:
  Last Updated: March 20, 2017
  Last Verified: March 2017