D. Portman, J. Edelson, R. Jordan
May 1, 2014
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Influential Citations
14
Citations
Quality indicators
Journal
Obstetrics & Gynecology
Abstract
INTRODUCTION: Bremelanotide is a novel heptapeptide melanocortin receptor-4 agonist. This study examined its subcutaneous self-administration by premenopausal patients with hypoactive sexual desire disorder, female sexual arousal disorder, or both and included exploratory analyses specifically in patients with hypoactive sexual desire disorder. METHODS: Premenopausal women with hypoactive sexual desire disorder, female sexual arousal disorder, or both underwent a no-treatment diagnosis-confirmation month followed by 4 weeks of single-blind, at-home placebo self-dosing (baseline). Patients were then randomized to double-blind placebo or bremelanotide at 0.75, 1.25, or 1.75 mg self-administered for 12 weeks. Outcomes included changes from baseline to end of study in the number of satisfying sexual events, Female Sexual Function Index scores, and Female Sexual Distress Scale—Desire/Arousal/Orgasm scores. RESULTS: Of 327 at-home study-drug users, 281 either had mixed hypoactive sexual desire disorder and female sexual arousal disorder with a primary diagnosis of hypoactive sexual desire disorder (n=206) or had solely hypoactive sexual desire disorder (n=75). Among all 281 women, mean satisfying sexual events change (per 4 weeks) was +0.2 for placebo compared with +0.8 for 0.75 mg, +0.7 for 1.25 mg, and +0.7 for 1.75 mg. Mean Female Sexual Function Index change was +1.55 compared with +1.45, +3.11, and +4.24 for total score and +0.37 compared with +0.33, +0.58, and +0.97 respectively for desire subscore. Mean Female Sexual Distress Scale—Desire/Arousal/Orgasm change was −6.6 compared with −8.0, –9.6, and −12.7 for total score and −0.6 compared with −0.5, –0.7, and −1.0 for question 13 (“bothered by low desire”). On all outcomes, bremelanotide benefit was statistically significant (P<.05, Van Elteren test) at 1.75 mg. CONCLUSIONS: In premenopausal hypoactive sexual desire disorder, subcutaneous bremelanotide yielded improvements across all key hypoactive sexual desire disorder measures with robust dose-dependence attaining statistical significance at 1.75 mg.