Clinical Trial: Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

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

Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual

Brief Summary: This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Detailed Summary:
Sponsor: BioSante Pharmaceuticals

Current Primary Outcome: The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects. [ Time Frame: 2011 primary outcome analysis for NDA submission ]

Original Primary Outcome: The rate of adjudicated, predefined cardiovascular and breast cancer events in LibiGel-treated subjects compared to that of placebo-treated subjects. [ Time Frame: 2010 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: BioSante Pharmaceuticals

Dates:
Date Received: January 23, 2008
Date Started: January 2008
Date Completion:
Last Updated: January 4, 2013
Last Verified: January 2013