Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
Kingsberg SA, Clayton AH, Portman D, et al. (2019). Obstetrics & Gynecology.
Summary
The two phase 3 trials behind the drug's US approval. Premenopausal women with hypoactive sexual desire disorder were randomised to bremelanotide, self-administered subcutaneously as needed, or placebo for 24 weeks. Both co-primary endpoints favoured bremelanotide: sexual desire scores rose and distress related to low desire fell, with statistically significant differences from placebo in both studies. The size of the change was small in absolute terms, around a third of a point on each scale. Nausea, flushing and headache each affected at least one in ten participants in both studies. Funded by the companies developing the drug.