ORIGINAL RESEARCH—FSD PHARMACOTHERAPY Evaluation of the Safety and Efficacy of Bremelanotide, a Melanocortin Receptor Agonist, in Female Subjects with Arousal Disorder: A Double-Blind Placebo-Controlled, Fixed Dose, Randomized Study Mohammad Reza Safarinejad, MD Urology and Nephrology Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran DOI: 10.1111/j.1743-6109.2007.00698.x ABSTRACT Introduction. Sexual arousal disorder affects about 30% of women worldwide and there are no effective drug treatments for the disorder. Aim. To evaluate the efficacy and safety of bremelanotide in menstruating women with female sexual arousal disorder (FSAD) as a sole entity. Methods. A total of 80 married women (mean age 31 years) with FSAD were randomly assigned to receive 20-mg bremelanotide as an intranasal spray (group 1, N = 40) on “as required” basis 45–60 minutes before attempting sexual intercourse, or a similar regimen of placebo (group 2, N = 40). The patients were asked to use at least 20 attempts at home. They underwent preliminary assessment, including medical and sexual history, blood chemistry, measure- ment of serum levels of sex hormones and prolactin, and self-administered Female Sexual Function Index (FSFI). Main Outcome Measures. Primary efficacy end points were FSFI questions 3–6 and 14–16. Secondary efficacy end points included the remaining items from this questionnaire. The efficacy of the two treatments was assessed every four attempts during treatment and at the end of study, using responses to FSFI and evaluation of total number of sexual events, total number of orgasm, personal distress, and adverse drug effects. Results. Mean pretreatment arousal score of 2.7 and 2.8 in groups 1 and 2 increased to 4.1 and 3.0, respectively, at the end of the trial (P = 0.001). The bremelanotide group reported significantly greater intercourse satisfaction than those in the placebo group (P = 0.001). More drug-related adverse effects occurred in the bremelanotide group and two (5%) had to discontinue treatment (P = 0.01). Conclusions. Bremelanotide was effective and well tolerated in menstruating women with FSAD as a sole entity. Further studies are required to draw final conclusions on the efficacy and safety of this drug in FSAD. Safarinejad MR. Evaluation of the safety and efficacy of bremelanotide, a melanocortin receptor agonist, in female subjects with arousal disorder: A double-blind placebo-controlled, fixed dose, randomized study. J Sex Med 2008;5:887–897. Key Words. Arousal Disorder; Melanocortin Agonist; Treatment; Bremelanotide Introduction O f the female sexual disorders (FSDs), female sexual arousal disorder (FSAD) is a highly prevalent problem. In a population study, Laumann et al. reported that the prevalence of FSD was 43% [1]. However, the reported rate of FSD from different countries is cultural and context dependent [2]. Women’s health, including sexual health, is a fundamental human right. Supported by evidence-based data, a step-care approach for the diagnosis and management of women with sexual health problems is advised [3]. FSAD is defined as “the persistent or recurrent 887 © 2007 International Society for Sexual Medicine J Sex Med 2008;5:887–897