Improved ejaculatory latency, control and sexual satisfaction when PSD502 is applied topically in men with premature ejaculation: results of a phase III, double-blind, placebo-controlled study.

摘要: ABSTRACT Introduction PSD502 is a novel aerosolized, lidocaine-prilocaine, spray being developed for the treatment of lifelong premature ejaculation. The clinical profile described in one two double-blind, placebo-controlled, phase III studies. Aim To determine effect on Index Premature Ejaculation (IPE) and intravaginal ejaculatory latency (IELT) men with PE. Methods Men PE who documented an IELT≤1 minute or more first three sexual encounters during 4-week baseline period were randomized to receive double-blind placebo 3 months. Patients completed IPE Profile questionnaires at entry monthly visits, recorded stop-watch timed IELT each encounter. Safety was assessed by collecting adverse event data standard safety measures. Main Outcome Measures Stopwatch recordings patient-reported outcome questionnaire used this study applied topically 5 minutes before intercourse. Results Two hundred fifty-six from 38 centers U.S., Canada, Poland. geometric mean over 3-month increased 0.56 0.53 group respectively 2.60 0.80 minute. There significantly greater increases scores domains control, satisfaction distress than group, 5.0 point difference between treatments change domain 4.6 satisfaction, 2.5 distress. This supported improvements all secondary endpoints. Conclusion In study, glans penis intercourse showed improved latency, shown be well tolerated patients partners. Carson C, Wyllie M. Improved control when ejaculation: III, placebo-controlled study.