In premenopausal women with hypoactive sexual desire disorder, bremelanotide 1.75 mg as needed was associated with statistically significant improvement in desire and reduction in associated distress versus placebo.
What is not established
Effect sizes were modest and their clinical meaningfulness has been debated. Evidence in men and postmenopausal women is not established.
Supporting sources (2)
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
Kingsberg SA, Clayton AH, Portman D, et al. · Obstetrics & Gynecology · 2019 · n = 1,267
- Population
- Premenopausal women with hypoactive sexual desire disorder
- Endpoint
- Change in FSFI desire domain and FSDS-DAO item 13 distress score
- Route
- Subcutaneous, as-needed
- Quantity as reported
- 1.75 mg as needed
- Frequency
- As needed, not more than once in 24 hours
- Duration
- 24 weeks
Result. Statistically significant improvement in desire and reduction in associated distress versus placebo. Effect sizes were modest.
Adverse events. Nausea, flushing, headache; transient blood-pressure increase and heart-rate decrease after dosing.
Limitations. Premenopausal women only. Effect sizes modest and of debated clinical meaningfulness. Not studied in men in these trials.
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide
Multiple · Journal of Women's Health · 2022 · n = 1,267
- Population
- Premenopausal women with HSDD, subgroup analysis
- Endpoint
- Subgroup consistency of desire and distress endpoints
- Route
- Subcutaneous
- Quantity as reported
- 1.75 mg as needed
- Frequency
- As needed
- Duration
- 24 weeks
Result. Reported broadly consistent direction of effect across prespecified subgroups.
Adverse events. As reported in the parent trials.
Limitations. Subgroup analyses are hypothesis-generating and underpowered individually.
Last evidence review: 2026-08-23