Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.
Spielmans. Glen I GI
Key Findings
- The original Phase III papers left out 73% of the outcomes they said they would measure and only reported a handful of secondary, post‑hoc results.
- Adverse events led to a much higher discontinuation rate on bremelanotide (OR ≈ 12, number needed to harm = 6).
- Participants were significantly more likely to stay on placebo and continue in the follow‑up study (OR ≈ 0.30, number needed to harm = 4).
- Overall, the modest efficacy reported is outweighed by safety concerns and poor participant preference.
Practical Outcomes
- For DIY health enthusiasts, bremelanotide does not appear to be a useful or safe option for boosting sexual desire. The high drop‑out rate and low preference suggest you’re better off exploring other, better‑studied interventions rather than self‑administering this peptide.
Summary
The analysis shows that bremelanotide (pt‑141) gives only small improvements in women's low sexual desire, but it causes many more side‑effects that make people drop out of studies, and most participants actually prefer staying on placebo. The original trial left out most of its planned results, so the drug’s real benefit is unclear and probably not worth the risk.
Abstract
Kingsberg et al. described results from two 24-week Phase III trials of bremelanotide for treating hypoactive sexual desire disorder (HSDD) in women. 72.72% of protocol-listed outcomes were not reported by Kingsberg et al., who provided results of 15 secondary measures which were not listed in the study protocols. None of their efficacy outcomes were reported in line with CONSORT data reporting standards and no secondary outcome had a stated rationale or cited evidence of validity. My meta-analysis of the trials' data, based on the FDA New Drug Application, found similar results to Kingsberg et al. However, Kingsberg et al. did not report that a) adverse event-induced study discontinuation was substantially higher on bremelanotide: OR = 11.98, 95% CI = 3.74-38.37, NNH: 6 or b) participants preferred placebo, measured by the combination of both 1) completing a clinical trial and 2) electing to participate in the follow-up open-label study (OR = 0.30, 95% CI = .24-.38, NNH: 4). Bremelanotide's modest benefits on incompletely reported post-hoc measures of questionable validity in combination with participants substantially preferring to take placebo suggest that the drug is generally not useful. Kingsberg et al.'s data reporting and measurement practices were incomplete and lacked transparency.
Study Information
pubmed
2021
2021-03-07T00:00:00.000Z
10.1080/00224499.2021.1885601
16
113