BioSante initiates Ph III trial of LibiGel

The USA's BioSante Pharmaceuticals has initiated a Phase III safety and efficacy trial of LibiGel (transdermal testosterone gel) in the treatment of female sexual dysfunction. The double-blind, placebo-controlled trial will assess approximately 360 surgically-menopausal women for a six-month period.

In a Phase II study, the agent significantly increased satisfying sexual events in women suffering from FSD. The results showed that LibiGel increased the number of these events a massive 238% versus baseline (p<0.0001), which was significant vs placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for premenopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject on LibiGel, BioSante noted.