Testosterone: Phase III data

Top-line data from the double-blind, North American Phase III BLOOM-2 trial in 575 surgically menopausal women showed that transdermal LibiGel missed the co-primary endpoints of significantly increasing the total number of days with a satisfying sexual event (1 vs. 1.28 days, p=0.214) and of significantly increasing mean sexual desire from baseline to 6 months vs. placebo (p=0.48). On secondary endpoints, LibiGel non-significantly reduced sexual distress from baseline (p=0.26). LibiGel also increased free testosterone levels by 2.51 pg/mL from baseline to 6 months vs. 0.03 pg/mL for placebo. LibiGel was well tolerated. ...