BioSante Pharmaceuticals has completed enrollment of subjects in the first of two pivotal phase III LibiGel (testosterone gel) safety and efficacy trials, being conducted under an FDA-approved special protocol assessment (SPA) agreement.
LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
The ongoing phase III efficacy trials are double-blind, placebo-controlled trials enrolling approximately 500 surgically menopausal women. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238% versus baseline (p