PT-141 (bremelanotide) in hypoactive sexual desire and erectile dysfunction: effect on the anchor outcome
In the population defined for hypoactive sexual desire and erectile dysfunction, what is the effect of PT-141 (bremelanotide) compared with the comparator used in its contributing trials on the anchor outcome for this indication?
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§1Abstract
§1.1Review question
In the population defined for hypoactive sexual desire and erectile dysfunction, what is the effect of PT-141 (bremelanotide) compared with the comparator used in its contributing trials on the anchor outcome for this indication?
§1.2PICO frame
Table 1. The registered PICO frame. Any change made after protocol registration is recorded in the amendment log at §5 and is identified there as post hoc.
| Element | As registered |
|---|---|
| Population | Persistently reduced sexual desire or impaired erectile function causing distress, assessed by validated instruments. |
| Intervention | PT-141 (bremelanotide) administered as subcutaneous, on demand. |
| Comparator | The comparator used in each contributing trial, reported per trial rather than pooled across comparator types. |
| Outcomes | Anchor outcome for this indication: Female Sexual Function Index desire domain. Additional outcomes: Female Sexual Distress Scale item 13; International Index of Erectile Function; Satisfying sexual events. |
§1.3Method in brief
A review of the effects of an intervention on pre-specified outcomes, with a quantitative synthesis where the contributing studies are sufficiently similar. The protocol was registered with the Institute's secretariat before the search was executed. The search was run on 16 October 2025 across 8 sources and is reproduced in full at §2. Screening, extraction and certainty assessment were performed independently by two members of the secretariat with disagreement resolved by a third.[1,2]
§1.4Conclusion
Moderate certainty evidence from 2 contributing trials bears on the effect of PT-141 (bremelanotide) on the anchor outcome for hypoactive sexual desire and erectile dysfunction. The estimate the Institute carries in the monograph is: Change in Female Sexual Function Index desire domain of +0.30 versus +0.06 with placebo, and improvement in the Female Sexual Distress Scale item 13 of −0.73 versus −0.41. Two identical phase 3 trials with statistically significant but small effects on validated instruments. The Institute reports the effect size on the original scale precisely because the statistical significance and the clinical magnitude diverge here, and readers should be able to see both.
The conclusion rests on 2 contributing studies, listed with their extracted data at §3 and summarised outcome by outcome at §4.
§1.5Limitations
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.