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Womens Health (Lond). 2016 Jun;12(3):325-37. doi: 10.2217/whe-2016-0018. Epub 2016 May 16.

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

Author information

1
University of Virginia, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA.
2
Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
3
University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
4
Maryland Center for Sexual Health, 1300 York Road, Lutherville, MD 21093, USA.
5
Seattle Women's Health, Research, Gynecology, 3216 NE 45th Place, Seattle, WA 98105, USA.
6
San Diego Sexual Medicine/Alvarado Hospital & Medical Center, 6655 Alvarado Road, San Diego, CA 92120, USA.
7
Manhattan Medical Research, 215 Lexington Avenue, New York, NY 10016, USA.
8
Palatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
9
Columbus Center for Women's Health Research, 99 North Brice Road, Columbus, OH 43213, USA.

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).

KEYWORDS:

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

PMID:
27181790
PMCID:
PMC5384512
DOI:
10.2217/whe-2016-0018
[Indexed for MEDLINE]
Free PMC Article

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