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 independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase 3 cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications.
The Phase 3 LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including, for example, hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase 3 cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53%. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33%, which is in line with the ages of the subjects enrolled in the study.
LibiGel is a topical testosterone gel that is absorbed through the skin and delivers testosterone to the bloodstream over time.
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