Sexual health · Phase 2
Bremelanotide: phase 2 sexual-function study
What was tested?
Bremelanotide versus placebo in premenopausal women with selected sexual-function disorders. ↗
Registered primary question: Change in the number of satisfying sexual events per month during 12 weeks of randomized treatment. ↗
What the reviewed report found
Journal year 2016 · Article summary reviewed 2026-09-15
The pooled active groups improved reported satisfying sexual events and questionnaire measures compared with placebo; nausea, flushing and headache were reported.↗
Keep in context: The registry lists 612 enrolled while the report describes 327 in its efficacy population. The positive result pools selected treatment groups; this phase 2 endpoint should not be substituted for the endpoints of later trials. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Why the participant counts differ
The full text reports 612 enrolled, 397 randomized, 394 in the safety population, 327 with the follow-up needed for efficacy analysis, and 293 completers. These counts describe different stages, not conflicting estimates of the same population. Full text ↗ · Indexed abstract ↗
Sections: Participant flow.
Primary result versus exploratory secondary findings
The primary comparison pooled two treatment groups. The first secondary endpoint in the prespecified testing sequence was not significant, so the paper treats all secondary endpoints as exploratory, with nominal p values. Favorable secondary results do not override that testing hierarchy. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Efficacy.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 612 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Triple
- Design
- Parallel
- Eligible ages
- 21 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2014-12-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 dose-finding study
- Design in the report
- A randomized placebo-controlled study assessed outcomes over 12 weeks.↗
- Participants in the report
- The efficacy analysis included 327 premenopausal women with female sexual dysfunction.↗
- Limitations
- Pooled exposure groups, a different primary endpoint and short follow-up limit comparison with phase 3 results. This report is not a head-to-head comparison with another medicine.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder ↗
Protocol identifier: PT-141-54. Sponsor: Palatin Technologies, Inc.
Retrieved 2026-09-20; SHA-256 0e9971330707a6792368559e48077fa89a73022185e50420cb6c16bb22d2aff3.
PMID 27181790
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 27181790. SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 2b56148504fb42c6a6ddb2af9b93818c62391301435cd29c35789f40d60e2ea7.
Selected full text: PMC5384512
Retrieved 2026-09-20; SHA-256 5f3ed19a1ea4f1fb136b35b91fc9f2dbeaa9d4d30f748dc67de198db63cea00f. Section identifiers and hashes are included in the cited study data.