Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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.
What This Study Doesn't 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.
Trust & Context
- Original Title:
- Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.
- Published In:
- Journal of sex research, 58(9), 1085-1105 (2021)
- Authors:
- Spielmans, Glen I
- Database ID:
- RPEP-05787
Evidence Hierarchy
Combines results from multiple studies to find an overall pattern.
What do these levels mean? →Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-05787APA
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
MLA
Spielmans, Glen I. "Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.." Journal of sex research, 2021. https://doi.org/10.1080/00224499.2021.1885601
RethinkPeptides
RethinkPeptides Research Database. "Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive ..." RPEP-05787. Retrieved from https://rethinkpeptides.com/research/spielmans-2021-reanalyzing-phase-iii-bremelanotide
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.