Two phase 3 trials studied a defined population
In 2019, two placebo-controlled phase 3 trials randomised 1,267 premenopausal women with hypoactive sexual desire disorder, persistent low sexual desire that causes distress. Bremelanotide improved desire and distress measures. Nausea, flushing and headache were more common than with placebo. The pooled safety and efficacy populations were 1,247 and 1,202 women, respectively.
Bremelanotide for hypoactive sexual desire disorder: two randomised phase 3 trials (2019)