Sexual health · Phase 3
Bremelanotide: RECONNECT study 301
What was tested?
Bremelanotide versus placebo in premenopausal women with acquired, generalized hypoactive sexual desire disorder. ↗
Registered primary question: Changes in the Female Sexual Function Index desire score and the Female Sexual Distress Scale item concerning distress about low desire; the registry includes the core study and extension observation periods. ↗
What the reviewed report found
Journal year 2019 · Article summary reviewed 2026-09-20
Compared with placebo, the reported treatment differences were +0.30 points on the desire measure and −0.37 points on the related-distress measure.↗
Keep in context: The selected report concerns the 24-week blinded core study. It reports improvement in both primary scales; the prespecified secondary count of satisfying sexual events did not differ significantly. ↗↗
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.
Use this trial’s analysis population
Study 301 included 643 participants in its safety population and 630 in its modified intention-to-treat efficacy population. The paper’s 1,267 randomized participants combine both trials; registry enrollment is also a different denominator. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
A favorable post hoc measure does not replace the failed endpoint
The prespecified count of satisfying sexual events did not differ significantly between groups. Subsequent ranked endpoints therefore became exploratory. The later favorable percentage of encounters that were satisfying was a separate post hoc analysis. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
Withdrawal and missing observations matter
The primary analysis carried the last observation forward. Study 301 withdrawal was 41.9% versus 16.0% for bremelanotide and placebo. The paper’s predominantly white US population and its exclusions limit generalization. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS; DISCUSSION.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 723 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Triple
- Design
- Parallel
- Eligible ages
- 18 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2021-04-09; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
RECONNECT: study 301
- Design in the report
- A randomized, double-blind, placebo-controlled trial assessed changes in desire and related distress during a 24-week treatment period.↗
- Participants in the report
- Premenopausal women with hypoactive sexual desire disorder participated. The abstract reports 1,267 randomized participants across both RECONNECT trials, not a separate study 301 total.↗
- Limitations
- These are study 301 results from the selected abstract. Its combined trial totals and integrated effect estimates must not be assigned to this trial alone. Nausea, flushing and headache were more frequent with bremelanotide in both trials.↗
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
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder ↗
Protocol identifier: BMT-301. Sponsor: Palatin Technologies, Inc.
Retrieved 2026-09-20; SHA-256 4fe25a9a7388f74477bbe2bc39f04102b2d41790b1cc6fa5a4a48e6ce27ff96d.
PMID 31599840
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. PubmedArticle[MedlineCitation/PMID=31599840] in the retained EFetch batch. SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Selected full text: PMC6819021
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder ↗
Retrieved 2026-09-20; SHA-256 d939a9d3502b7945efc876a08c392a8d6c4de8cd6a36f2e1dc0c06daa03199bb. Section identifiers and hashes are included in the cited study data.