LibiGel testosterone: Phase III ongoing

For a fourth time, a DMC recommended continuation of a Phase III safety trial evaluating transdermal LibiGel for 12 months based on a review of unblinded safety data and statistical analysis for sample-size determination in 2,500 patients. The double-blind, placebo-controlled, international study is designed to enroll 2,400-4,000 patients. The company has an SPA from FDA for the trial. Last month, BioSante reported interim data from 2,300 evaluable patients showing that the rates of cardiovascular and breast cancer events were 0.65% and 0.32%, respectively, after about 10.5 months of LibiGel treatment (see BioCentury, Oct. 25). ...