Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial. (June 2016)

• Record Type: Journal Article
• Authors: Clayton, Anita H; Althof, Stanley E; Kingsberg, Sheryl; DeRogatis, Leonard R; Kroll, Robin; Goldstein, Irwin; Kaminetsky, Jed; Spana, Carl; Lucas, Johna; Jordan, Robert; Portman, David J
• Is Part Of: Women's health. Volume 12:Number 3(2016)
• Page Start: 325
• Page End: 337
• Publication Date: 2016-06
• Subjects: bremelanotide -- female sexual arousal disorder -- female sexual dysfunction -- FSD -- hypoactive sexual desire disorder -- HSDD; Gynecology -- Periodicals; Obstetrics -- Periodicals; Women -- Health and hygiene -- Periodicals; 618.05
• DOI: 10.2217/whe-2016-0018
• Languages: English
• ISSNs: 1745-5057

Abstract

Aim: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.Methods: Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm.Results: Efficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), −11.1 versus −6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache. Conclusion: In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).