Safety and Efficacy of Epelsiban in the Treatment of Men with Premature Ejaculation: A Randomized, Double‐Blind, Placebo‐Controlled, Fixed‐Dose Study

To assess the efficacy and safety of the selective oxytocin receptor antagonist epelsiban in the treatment of premature ejaculation (PE). Double‐blind, randomized, parallel‐group, placebo‐controlled, stopwatch‐monitored, phase 2, multicenter study (GSK557296; NCT01021553) conducted in men (N = 77) 18–55 years of age, with PE defined as per International Society for Sexual Medicine consensus definition. Patients provided informed consent prior to a 4‐week un‐medicated run‐in to determine baseline intravaginal ejaculatory latency times (IELT) recorded in an electronic diary. Patients needed to make a minimum of four intercourse attempts and have a mean IELT