Melanotan-II in hypoactive sexual desire and erectile dysfunction — evidence extract
The Institute's graded assessment of Melanotan-II 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
- Melanotan-II, subcutaneous in unregulated use
- 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
No trial has been identified for Melanotan-II in hypoactive sexual desire and erectile dysfunction. The rating below reflects that absence.
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Allocation concealment is not described in one contributing report. |
| Inconsistency | Very serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| 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: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§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
- Carvalho M, Dinis-Oliveira RJ. Analytical and forensic aspects of counterfeit peptide hormones. Drug Testing and Analysis 2023;15(1):5–19. doi:10.1002/dta.3379
- Medicines and Healthcare products Regulatory Agency. Falsified Ozempic (semaglutide) pens: patient safety alert. MHRA Safety Alert 2023;Alert reference NatPSA/2023/012/MHRA. identifier not held by the Institute
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.