BioSante Pharmaceuticals has announced the top-line results from its two pivotal Phase III efficacy trials of LibiGel (testosterone gel), used for the treatment of postmenopausal women who suffer from female sexual dysfunction, specifically hypoactive sexual desire disorder.
The two Phase III efficacy trials, BLOOM-1 and BLOOM-2, were randomised, double-blind and placebo-controlled. They enrolled 597 and 575 surgically menopausal women, respectively, for six-months of therapy.
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. Secondary endpoints included the change in sexual distress from baseline.
In the first trial, BLOOM-1, subjects treated with LibiGel reported an increase of 1.47 days with a satisfying sexual event, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline.
Subjects in the LibiGel group demonstrated an improvement in the total number of satisfying sexual events of 3.87 from baseline and in the placebo group there was an increase of 3.52 satisfying sexual events from baseline.
In the BLOOM-2 trial, subjects in the LibiGel group showed an increase of one day with a satisfying sexual event, while those receiving placebo gel showed an increase of 1.28 days with a satisfying sexual event compared to baseline.
The BLOOM-1 trial also demonstrated an increase in mean sexual desire of 0.03 over placebo, while subjects in BLOOM-2 showed an improvement in mean sexual desire of 0.03 versus placebo.
BioSante president and CEO Stephen Simes said that the company would continue to examine the efficacy trial data fully and determine plans for the next steps in the LibiGel development plan.
''While the LibiGel Phase III cardiovascular and breast cancer safety study currently continues as planned, we will be analysing the best path forward for the study given the results reported today,'' Simes added.
Both the trials revealed that subjects when treated with LibiGel demonstrated a decrease in sexual distress and an increase in free testosterone levels compared to baseline and placebo.