DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol.
LibiGel is a testosterone gel used to treat female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD) in menopausal women.
The Phase III LibiGel randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study has enrolled 3,656 women.