The two randomized double-blind placebo-controlled trials Phase III efficacy trials- BLOOM-1 and BLOOM-2 enrolled 597 and 575 surgically menopausal women, respectively, for six-months of therapy.
In the BLOOM-1 trial, subjects treated with LibiGel showed an increase of 1.47 days with a satisfying sexual event compared to 1.26 days those receiving placebo gel, and also demonstrated an increase in the total number of satisfying sexual events of 3.87 from baseline versus 3.52 for the placebo group.
The BLOOM-2 trial also reported that subjects in the LibiGel group showed an increase of one day with a satisfying sexual event, compared with an increase of 1.28 days in those receiving placebo gel.
Subjects in the BLOOM-1 trial showed an increase in mean sexual desire of 0.03 over placebo, while subjects in BLOOM-2 reported an improvement of 0.03 in mean sexual desire versus placebo.
The co-primary endpoints of both LibiGel efficacy trials were the change in the total number of days with a satisfying sexual event from baseline, and the change in mean sexual desire from baseline, and the secondary endpoint included the change in sexual distress from baseline.
In both the trials, subjects treated with LibiGel demonstrated a decrease in sexual distress and an increase in free testosterone levels compared to baseline and placebo.