drugset / Trial / NCT00612742

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

NCT00612742

Phase 3 Completed 3656 enrolled BioSante Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2008-01
Primary completion
2012-10
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 300 ug Other