Bremelanotide

Does Bremelanotide work?

Yes, in two controlled trials of 1,267 women, though the gains were small.

Approval rests on the two RECONNECT phase 3 trials, which randomized 1,267 premenopausal women and met their co-primary endpoints on desire and distress questionnaires. The effect sizes were small, the number of satisfying sexual events did not increase, dropout for nausea was high, and an independent reanalysis questioned the validity of the outcome questionnaires. Approved on RCTs but with surrogate questionnaire endpoints and contested benefit is grade B. ⁴⁵

The RECONNECT programme ran two identical randomized, double-blind, placebo-controlled trials. Each lasted 24 weeks. Together they enrolled 1,267 premenopausal women with HSDD. They were published in Obstetrics & Gynecology in 2019. Both trials met their two main goals. On the desire domain of the Female Sexual Function Index, women on the drug scored about 0.3 to 0.4 points better than placebo, on a 1.2 to 6 scale. On the distress item of the Female Sexual Distress Scale, they scored about 0.3 points better, on a 0 to 4 scale. ⁴

A key secondary goal was the number of satisfying sexual events per month. It did not differ from placebo. Roughly 18% of women on bremelanotide dropped out because of side effects, against about 2% on placebo. In 2023, an independent reanalysis in the Journal of Sex Research looked at the data again. It found little proof that the questionnaires are valid in women with HSDD. It also found that 8 of the 11 outcomes registered on ClinicalTrials.gov had gone unpublished. Effect sizes on those outcomes ranged from nil to small. ⁴⁵

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Reference information only, not medical advice. Drawn from the Bremelanotide article, fact-checked against the cited sources. No dosing anywhere on this site.