Study summary · research use only
Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This paper re-analyzes two 24-week Phase III trials of bremelanotide for hypoactive sexual desire disorder (HSDD) in women, originally described by Kingsberg et al. The author reports that 72.72% of protocol-listed outcomes were not reported by Kingsberg et al., who instead reported 15 secondary measures not listed in the protocols, and states no outcome was reported per CONSORT standards. A meta-analysis of the FDA data found similar results, but noted higher adverse-event-induced discontinuation with bremelanotide (OR = 11.98, 95% CI 3.74-38.37, NNH: 6) and greater participant preference for placebo (OR = 0.30, 95% CI .24-.38, NNH: 4). The author concludes bremelanotide's benefits on incompletely reported measures, combined with preference for placebo, suggest the drug is generally not useful, and describes the reporting as incomplete and lacking transparency.
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.
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