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