Distress reduction in female sexual dysfunctions: a dose-ranging study of subcutaneous bremelanotide.

INTRODUCTION: Bremelanotide is a novel heptapeptide melanocortin receptor-4 agonist. This study examined its subcutaneous self-administration on an at-home, as-needed basis by premenopausal patients with female sexual dysfunctions. Efficacy measures included the 15-item, Female Sexual Distress Scale-Desire/Arousal/Orgasm questionnaire.

METHODS: Premenopausal women with hypoactive sexual desire disorder, female sexual arousal disorder, or both received an in-clinic placebo dose followed by 1-week monitoring and then 4 weeks of at-home placebo self-dosing (baseline period). Participants then were randomized to placebo or bremelanotide at 0.75, 1.25, or 1.75 mg, self-administered twice in-clinic and then for 12 weeks at home. Female Sexual Distress Scale-Desire/Arousal/Organism score changes from baseline to end of study were analyzed by the Van Elteren test.

RESULTS: Among 327 at-home study-drug users, mean (standard deviation) baseline Female Sexual Distress Scale-Desire/Arousal/Orgasm total score was 30.5-33.3, depending on treatment group. On Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 ("feeling bothered by low sexual desire"), mean baseline scores were 2.4-2.7. Mean (standard deviation) changes in total score were -6.8 (13.57) for placebo compared with -7.4 (13.47) for 0.75 mg, -9.2 (10.79) for 1.25 mg, -13.1 (12.93) for 1.75 mg, and -11.1 (12.02) for 1.25 and 1.75 mg pooled. Bremelanotide benefit was statistically significant (P<.05) at 1.75 mg and for 1.25 and 1.75 mg pooled. On item 13, mean changes were -0.6 (1.25) compared with 0.5 (1.07), -0.7 (1.03), -1.1 (1.16), and -0.9 (1.11) with statistical significance for 1.75 mg individually and 1.75 and 1.25 mg pooled.

CONCLUSIONS: In premenopausal women with female sexual dysfunctions, subcutaneous bremelanotide reduced sexually related distress, including distress regarding feeling bothered by low sexual desire, with statistical significance at 1.75 mg.