Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.
Clayton. Anita H AH; Althof. Stanley E SE; Kingsberg. Sheryl S; DeRogatis. Leonard R LR; Kroll. Robin R; Goldstein. Irwin I; Kaminetsky. Jed J; Spana. Carl C; Lucas. Johna J; Jordan. Robert R; Portman. David J DJ
Key Findings
- BMT 1.25 mg/1.75 mg increased satisfying sexual events/month by about 0.5 more than placebo (+0.7 vs +0.2).
- Total Female Sexual Function Index scores rose 3.6 points with BMT versus 1.9 points with placebo.
- Female Sexual Distress scores dropped more with BMT (‑11.1) than placebo (‑6.8), indicating less distress.
- Adverse events were generally mild (nausea, flushing, headache) and the drug was well tolerated.
Practical Outcomes
- For self‑experimenters interested in enhancing sexual health, a subcutaneous dose of 1.25–1.75 mg of bremelanotide taken as needed appears effective and safe. Start with the lower dose to gauge tolerance, monitor for mild nausea or flushing, and adjust upward if needed. Use a sterile insulin‑type syringe or auto‑injector, and track changes in sexual satisfaction and any side effects over a few weeks.
Summary
A study in premenopausal women with sexual problems found that taking the peptide bremelanotide (BMT) under the skin, on an as‑needed basis, boosted the number of satisfying sexual events and improved overall sexual function scores. Doses of 1.25 mg or 1.75 mg worked better than placebo, with common side effects being mild nausea, flushing, and headache.
Abstract
Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women. 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. 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. In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).
Study Information
pubmed
2016
2016-05-16T00:00:00.000Z
10.2217/whe-2016-0018
85
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