BioSante Initiates Phase III Female Sexual Dysfunction Study
Posted on: Wednesday, 9 January 2008, 12:00 CST
BioSante Pharmaceuticals has initiated a Phase III safety study of LibiGel for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder.
The Phase III safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. A new drug application (NDA) can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.
The primary focus of BioSante's LibiGel Phase III safety study is to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA. The final study protocol seeks to show the relative safety of using a low dose testosterone versus placebo in the treatment of female sexual dysfunction (FSD) in menopausal women.
The LibiGel safety study will track a list of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least one cardiovascular risk factor including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.
Stephen Simes, president & CEO of BioSante, said: "BioSante is committed to the development of LibiGel which if approved by the FDA could be the first product approved for this treatment in the US."
Source: Datamonitor
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