#Grand Rounds

RCT Results: Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder

BACKGROUND AND PURPOSE:

Kingsberg et al. (Obstetrics & Gynecology, 2019) analyzed the safety and efficacy of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD)

Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT)
Participants
- Premenopausal women with HSDD
Groups
- 24 weeks of treatment with bremelanotide
  - Bremelanotide 1.75 mg subcutaneously as needed
- Placebo
Primary outcomes
- Change from baseline to end-of-study in the
  - Female Sexual Function Index–desire domain score
  - Female Sexual Distress Scale–Desire/Arousal/Orgasm item 13

1,267 women were included
- Mean age: 39 years
Compared to placebo, women taking bremelanotide had statistically significant increases in sexual desire (integrated studies: P < 0.001)
Statistically significant reductions in distress related to low sexual desire (integrated studies: P < 0.001)
Effect size (‘effect size of 0.2 is considered small, 0.5 medium, and 0.8 large’)
- Improving sexual desire: 0.39
- Reducing related distress was 0.27
Adverse events
- Bremelanotide use vs placebo was associated with more nausea, flushing, and headache (10% or more in both studies)

Bremelanotide use in premenopausal women significantly improved sexual desire and reduced stress related to HSDD
Most adverse effects were considered mild or moderate
- A 52 week open-label extension of the above trial (see ‘Learn More – Primary Sources’) did not identify additional safety signals, while outcomes related to sexual desire improvement appeared to be sustained

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