Clinical Trial: Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

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

Official Title:

Brief Summary: The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Detailed Summary:
Sponsor: EndoCeutics Inc.

Current Primary Outcome:

  • Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]
    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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
  • Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]
    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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
  • Change From Baseline to Week 12 in Vaginal pH [ Time Frame: Baseline and Week 12 ]
    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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
  • Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia [ Time Frame: Baseline an

    Original Primary Outcome:

    • Vaginal Maturation Index (percentage of superficial and parabasal cells) [ Time Frame: 12 weeks ]
    • Vaginal pH [ Time Frame: 12 weeks ]
    • Vulvovaginal atrophy symptom [ Time Frame: 12 weeks ]


    Current Secondary Outcome:

    • Change From Baseline to Week 12 in Severity of Vaginal Dryness [ Time Frame: Baseline and Week 12 ]
      The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
    • Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions [ Time Frame: Baseline and Week 12 ]
      To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
    • Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity [ Time Frame: Baseline and Week 12 ]
      To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
    • Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness [ Time Frame: Baseline and Week 12 ]
      To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
    • Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color [ Time Frame: Baseline and Week 12 ]
      To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, 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. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.


    Original Secondary Outcome: Tolerance to intravaginal prasterone administration [ Time Frame: From Day 1 to 12 weeks ]

    Tolerance to treatment will be evaluated by the aspect of the vaginal mucosa (namely evaluation of vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal color) at gynecological examinations to be performed at screening, Day 1, Week 6 and Week 12.


    Information By: EndoCeutics Inc.

    Dates:
    Date Received: December 9, 2013
    Date Started: February 2014
    Date Completion:
    Last Updated: May 30, 2017
    Last Verified: May 2017