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
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
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
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
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