FDAnews
www.fdanews.com/articles/105228-safety-efficacy-of-libigel-under-review

Safety, Efficacy of LibiGel Under Review

March 25, 2008

BioSante Pharmaceuticals has started the second of two Phase III safety and efficacy trials of LibiGel to treat female sexual dysfunction.

The double-blind, placebo-controlled LibiGel (transdermal testosterone gel) trial will enroll approximately 500 surgically menopausal women for six months. The company also is enrolling women in a second Phase III safety study.

The primary endpoints of the two trials are an increase in the number of satisfying sexual events and sexual desire with a secondary endpoint of a decrease in sexual distress, BioSante said.