This record provides bibliographic details and links to the original research. An editorial study breakdown is not available.
What the researchers found
Bremelanotide re-analysis showed 72.7% of protocol outcomes unreported, adverse event dropout OR=11.98 (NNH: 6), and participants preferred placebo (OR=0.30, NNH: 4) based on trial completion and open-label enrollment.
Why it matters
Approved drugs should have clear evidence of meaningful benefit. This re-analysis raises serious concerns about the transparency and validity of the data supporting bremelanotide's approval for HSDD.
The numbers in context
72.7% protocol outcomes unreported; 15 non-protocol secondary measures added; adverse dropout OR 11.98 (NNH 6); participant preference OR 0.30 favoring placebo (NNH 4)
How the study worked
Meta-analysis of two phase III RCTs using FDA New Drug Application data. Re-analyzed efficacy and safety outcomes, compared to protocol-specified endpoints, and assessed participant preference through trial completion and open-label enrollment.
Who was studied
Premenopausal women with hypoactive sexual desire disorder across two 24-week phase III RCTs of bremelanotide
What this study cannot tell us
Re-analysis based on publicly available FDA data, which may not include all trial details. The author's interpretation of participant preference (completing trial + enrolling in open-label) is one of several possible measures. The original authors may have additional context.
Read the original research
Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.
Journal of sex research, 58(9), 1085-1105
Citation
Spielmans, Glen I. (2021). Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.. Journal of sex research, 58(9), 1085-1105. https://doi.org/10.1080/00224499.2021.1885601