BioSante Completes Patient Enrolment in LibiGel Study
BioSante Pharmaceutical said the ability to top enrolment as per the sample size analysis indicates a 90% predictive probability of success of the LibiGel Phase III clinical development programme.
BioSante Pharmaceuticals has completed patient enrolment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is used for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder in menopausal women.
The company reported that the independent Data Monitoring Committee reviewed unblinded data in over 3,250 women enrolled in the study – equivalent to over 3,450 years of exposure –including 22 adjudicated cardiovascular events.
BioSante Pharmaceutical president & CEO Stephen Simes said that the ability to top enrolment as per the sample size analysis indicates a 90% predictive probability of success of the LibiGel Phase
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