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news.BioSante Pharmaceuticals has announced that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study.
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LibiGel, a testosterone gel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
LibiGel, when applied once-daily on the upper arm is absorbed quickly through the skin, delivering testosterone to the bloodstream evenly over time.
The randomized double-blind placebo-controlled multi-center cardiovascular (CV) events and breast cancer study has enrolled a total of 3,656 subjects.
The aim of the safety study is to evaluate the relative safety of testosterone and incidence of breast cancer versus placebo in the number of CV events.
The DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without any changes, as there were no general or specific safety issues based on their unblinded review of adverse events.