Three selected reports cover a phase 2 dose-finding trial, the two phase 3 RECONNECT trials, and a safety analysis that reuses development-program participants. Other populations and formulations are outside this synthesis.123
Bottom line from this bounded source set
RECONNECT reported improvements in desire and related distress in premenopausal women with hypoactive sexual desire disorder. Nausea, flushing and headache were more frequent with bremelanotide. Safety analyses overlap the efficacy-trial population.123
Reviewed study record
RECONNECT: two phase 3 trials
Design
Two blinded randomized placebo-controlled trials assessed 24-week changes in desire and distress scores.1
Population
Of 1,267 premenopausal women randomized, 1,247 were in the safety population and 1,202 in the efficacy population; most were White and enrolled in the United States.1
Outcomes reported
Both studies reported improvements in the two primary symptom scores compared with placebo. Nausea, flushing and headache occurred more often with bremelanotide.1
Limitations
The endpoints were questionnaire scores in a selected population. These results do not establish benefit in other sexual disorders or demographic groups.1
Reviewed study record
Development-program safety analysis
Design
An integrated report reviewed safety across clinical development, including the RECONNECT randomized and open-label periods.2
Population
The program included approximately 3,500 participants across 43 studies; the integrated blinded phase 3 analysis included 1,247.2
Outcomes reported
Nausea was the most common reason for stopping bremelanotide. The report also described transient blood-pressure increases and focal hyperpigmentation.2
Limitations
The integrated data overlap other trial reports and cannot be counted as an independent replication. Open-label continuation introduces selection and attrition.2
Reviewed study record
Phase 2 dose-finding study
Design
A randomized placebo-controlled study assessed outcomes over 12 weeks.3
Population
The efficacy analysis included 327 premenopausal women with female sexual dysfunction.3
Outcomes reported
The pooled active groups improved reported satisfying sexual events and questionnaire measures compared with placebo; nausea, flushing and headache were reported.3
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.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1097/aog.0000000000003500. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1089/jwh.2021.0191. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.2217/whe-2016-0018. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗