ARTICLE | Clinical News

LibiGel testosterone: Phase III ongoing

February 13, 2012 8:00 AM UTC

For an eighth time, an independent DMC recommended continuation of a double-blind, placebo-controlled, international Phase III safety trial evaluating transdermal LibiGel for 12 months based on a review of safety data. The trial completed enrollment of 3,656 patients in June. Data from 3,656 evaluable patients showed that the rates of cardiovascular and breast cancer events were 0.53% and 0.33%, respectively.

In December, LibiGel missed the co-primary endpoints vs. placebo in the Phase III BLOOM-1 and BLOOM-2 trials to treat HSDD in menopausal women. LibiGel did not significantly increase the total number of days with a satisfying sexual event and also did not significantly increase mean sexual desire from baseline to 6 months vs. placebo in each trial (see BioCentury, Dec. 19, 2011). ...