Bremelanotide for female sexual dysfunctions in premenopausal women: A randomized, placebo-controlled dose-finding trial

Anita H. Clayton, Stanley E. Althof, Sheryl Kingsberg, Leonard Derogatis, Robin Kroll, Irwin Goldstein, Jed Kaminetsky, Carl Spana, Johna Lucas, Robert Jordan, David J. Portman

Research output: Contribution to journalArticle

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).

Original languageEnglish (US)
Pages (from-to)325-337
Number of pages13
JournalWomen's Health
Volume12
Issue number3
DOIs
StatePublished - Jun 1 2016
Externally publishedYes

Keywords

  • bremelanotide
  • female sexual arousal disorder
  • female sexual dysfunction
  • FSD
  • HSDD
  • hypoactive sexual desire disorder

ASJC Scopus subject areas

  • Medicine(all)

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  • Cite this

    Clayton, A. H., Althof, S. E., Kingsberg, S., Derogatis, L., Kroll, R., Goldstein, I., Kaminetsky, J., Spana, C., Lucas, J., Jordan, R., & Portman, D. J. (2016). Bremelanotide for female sexual dysfunctions in premenopausal women: A randomized, placebo-controlled dose-finding trial. Women's Health, 12(3), 325-337. https://doi.org/10.2217/whe-2016-0018