Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. Issue 9 (22nd November 2021)

• Record Type: Journal Article
• Authors: Spielmans, Glen I.
• Is Part Of: Journal of sex research. Volume 58:Issue 9(2021)
• Page Start: 1085
• Page End: 1105
• Publication Date: 2021-11-22
• Subjects: Sexology -- Research -- Periodicals; Sex -- Periodicals; Psychiatry -- Periodicals; Sex; Psychiatry; 306.705
• DOI: 10.1080/00224499.2021.1885601
• Languages: English
• ISSNs: 0022-4499

Abstract

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.