NCT00612742

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

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 Desire Disorder in Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,656 (actual)
• Sponsor: BioSante Pharmaceuticals · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	testosterone gel	once daily transdermal testosterone gel, 300 mcg
DRUG	placebo gel	once daily transdermal placebo gel

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2008-02-12
• Last updated: 2021-10-29

Locations

149 sites across 2 countries: United States, Canada