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#Grand Rounds

RCT Results: Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder

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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)

METHODS:

  • 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

RESULTS:

  • 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)

CONCLUSION:

  • 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

Learn More – Primary Sources:

Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (24 week RCT)

Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder (52 week open-label extension)

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Related ObG Topics:

Prescribing Bremelanotide for Low Desire: How, When and Where?
Treatment Options for the Patient with Low Sexual Desire
How Large is the Placebo Effect in Sexual Dysfunction Treatment Studies?
Could Flibanserin Treat Hypoactive Sexual Desire in Postmenopausal Women?
KEEPS Trial: What Are the Effects of Oral vs Transdermal Estrogen Therapy on Sexual Function?

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