Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial
Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ
Women's Health · Vol. 12(3) · pp. 325–337 · 2016
Phase 2b RCT establishing the efficacy and dose-response of bremelanotide (PT-141) for hypoactive sexual desire disorder (HSDD) in premenopausal women. Led to FDA approval of bremelanotide (Vyleesi) in 2019 — the first on-demand treatment for HSDD.
Key Findings
Significant improvement in satisfying sexual events vs. placebo at 1.75 mg dose
Improved desire, arousal, and reduced distress related to sexual dysfunction
On-demand dosing (45 min before activity) provides flexible treatment option
FDA approved bremelanotide (Vyleesi) based on this and subsequent Phase 3 data
Most common adverse effects: nausea, flushing, headache (generally mild and transient)
Methodology
Phase 2b double-blind RCT with dose-finding design. Premenopausal women with HSDD. Primary endpoint: change in satisfying sexual events per month.
Limitations
Nausea limits tolerability for some patients. Modest effect size vs. placebo. Not studied in postmenopausal women or men in this trial.
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