Clinical Trial: Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

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

Official Title: DHEA + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (Placebo Controlled, Double Blind and Randomized Phase III Study to Evaluate the Effects

Brief Summary: The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.

Detailed Summary:
Sponsor: EndoCeutics Inc.

Current Primary Outcome:

  • Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. [ Time Frame: 12 weeks ]
  • Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes. [ Time Frame: 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms). [ Time Frame: 12 weeks ]
  • Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires. [ Time Frame: 12 weeks ]
  • Tolerance to systemic administration of DHEA and acolbifene. [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: EndoCeutics Inc.

Dates:
Date Received: October 12, 2011
Date Started: October 2011
Date Completion:
Last Updated: December 10, 2013
Last Verified: December 2013