Testosterone: Phase III data
Top-line data from the double-blind, North American Phase III BLOOM-1 trial in 597 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 (1.47 vs. 1.26 days, p=0.463) and of significantly increasing mean sexual desire from baseline to 6 months vs. placebo (p=0.672). On secondary endpoints, LibiGel non-significantly reduced sexual distress from baseline (p=0.569). Additionally, patients receiving LibiGel had a non-significantly greater increase in the percentage of satisfying sexual events from baseline to 6 months vs. placebo (83% vs. 65%, p=0.698). LibiGel also increased free testosterone levels by 2.91 pg/mL from baseline to 6 months vs. 0.16 pg/mL for placebo. LibiGel was well tolerated. ...