Hypoactive sexual desire disorder (women)
Kingsberg 2019 (RECONNECT, n=1267 across two Phase 3 trials) randomized premenopausal women with acquired generalized HSDD to bremelanotide 1.75 mg SC PRN vs placebo for 24 weeks and showed significant improvements in desire and reduction in distress. FDA-approved 2019 (Vyleesi) — the second drug ever approved for female HSDD.
3 human studies · 6 animal studies
Key findings & citations
- RECONNECT: significant improvement in FSFI desire domain and FSDS-DAO item 13 vs placebo.
- Effect on satisfying sexual events was small (~0.5 events/month).
- Nausea ~40% — primary reason for discontinuation.
- Long-term 52-week extension confirmed safety profile (Simon 2019).
Our take
Approved drug with real but modest effect. Nausea is the primary reason most patients won't continue past a few doses.