Phase 3 study of LibiGel for female sexual dysfunction

BioSante announced positive safety data from ongoing Phase 3 trials of LibiGel (testosterone) for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women. The LibiGel safety study is a multicenter, randomized, double-blind, placebo-controlled, five-year, cardiovascular (CV) events and breast cancer study that has enrolled 2,869 women, with a maximum of 4,000 patients to be enrolled.

The study tracks a predefined list of CV events including CV death, myocardial infarction and stroke in women ≥50 years of age and suffering from at least two CV risk factors, including hypertension and diabetes, in patients receiving LibiGel. The incidence of breast cancer also is being tracked over the course of the study. In patients treated with LibiGel, there have been 17 adjudicated CV events, an event rate of about 0.57%. Eight breast cancers have been reported, a rate of approximately 0.27%.

LibiGel is a topical testosterone gel that is absorbed through the skin and delivers testosterone to the bloodstream over time.

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