Clinical Trial: Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

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

Official Title:

Brief Summary: The purpose of this Phase III trial is to evaluate 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 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Local tolerance to intravaginal administration of DHEA [ Time Frame: 12 weeks ]
  • Effect of intravaginal administration of DHEA on sexual function. [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: EndoCeutics Inc.

Dates:
Date Received: May 20, 2011
Date Started: June 2011
Date Completion:
Last Updated: February 19, 2016
Last Verified: February 2016