PT-141 (bremelanotide) in hypoactive sexual desire and erectile dysfunction — evidence extract
The Institute's graded assessment of PT-141 (bremelanotide) for hypoactive sexual desire and erectile dysfunction, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Hypoactive sexual desire and erectile dysfunction
§1.1Question and anchor outcome
- Population
- Persistently reduced sexual desire or impaired erectile function causing distress, assessed by validated instruments.
- Intervention
- PT-141 (bremelanotide), subcutaneous, on demand
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Female Sexual Function Index desire domain
Additional outcomes the Institute extracts for this indication: Female Sexual Distress Scale item 13; International Index of Erectile Function; Satisfying sexual events.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of PT-141 (bremelanotide) in hypoactive sexual desire and erectile dysfunction.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| RECONNECT-301 | 3 | Randomised, double-blind, placebo-controlled | 626 | 24 weeks | 2019 |
| RECONNECT-302 | 3 | Randomised, double-blind, placebo-controlled | 630 | 24 weeks | 2019 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
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
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
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.