Completed Phase III 2019
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT)
Kingsberg SA, Clayton AH, Portman D, et al.
Obstetrics and Gynecology
Summary
The RECONNECT program comprised two replicate, randomized, double-blind, placebo-controlled Phase 3 trials evaluating bremelanotide (PT-141), a melanocortin-4 receptor agonist, in 1,247 premenopausal women with hypoactive sexual desire disorder (HSDD). Subcutaneous bremelanotide 1.75 mg administered as needed significantly improved sexual desire and reduced distress related to low sexual desire.
Key Findings
- Bremelanotide significantly increased the Female Sexual Function Index desire domain score compared to placebo (p<0.001) in both trials
- Significant reductions in distress associated with low sexual desire were observed on the Female Sexual Distress Scale-Desire/Arousal/Orgasm (p<0.001)
- The most common adverse events were nausea (40%), flushing (20%), and headache (11%), with nausea generally mild and decreasing with repeated use
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