Study summary · research use only
Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This human study examined measurement properties of outcome measures from the phase III 'RECONNECT' bremelanotide trials in women with hypoactive sexual desire disorder (HSDD). The authors report the Female Sexual Function Index (FSFI) and its Desire domain, and the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) and its item #13, have questionable validity evidence for HSDD, and found no validity evidence for previously published categorical treatment response outcomes. The abstract states results on 8 of 11 clinicaltrials.gov-specified outcomes had been unpublished, including FSDS-DAO total score, FSFI total score, FSFI arousal domain, and Female Sexual Encounter Profile-Revised items; effect sizes ranged from nil to small, and other outcomes showing modest apparent benefits were likely derived post-hoc. The authors describe bremelanotide's benefits as statistically modest and limited to outcomes with scant validity evidence.
Abstract
Efficacy outcomes are only informative to the extent that they are validated. We examined the measurement properties of efficacy measures from the phase III ("RECONNECT") bremelanotide trials for hypoactive sexual desire disorder (HSDD) in women. Continuous efficacy outcomes, including a) the Female Sexual Function Index (FSFI) and its Desire domain (FSFI-D) and b) the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) and its item assessing distress due to low desire (FSDS-DAO #13) have questionable, at best, validity evidence for women with HSDD. We found no validity evidence for previously published categorical treatment response outcomes from the RECONNECT trials. All efficacy results should be reported, but results on 8 of the 11 clinicaltrials.gov-specified efficacy outcomes were heretofore unpublished (including FSDS-DAO total score, FSFI total score, FSFI arousal domain, and items from the Female Sexual Encounter Profile-Revised). We analyzed these outcomes, upon which effect sizes ranged from nil to small. Several other continuous and categorical outcomes generated modest apparent benefits, though nearly all of these outcomes were likely derived post-hoc. Across RECONNECT trial data from two prior publications and the current study, bremelanotide's benefits are statistically modest and limited to outcomes for which scant evidence of validity among women with HSDD exists.
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