원발성 조루증 환자에서 SS-cream의 임상시험 평가

Abstract

Purpose : To determine the clinical efficacy of SS-cream, the topical agent made from the extracts of natural products for treating premature ejaculation(PE), a double blind, randomized placebo controlled phase Ⅲ study on the patients with primary PE was performed in three medical centers. Materials and Methods : Mean age of patient with primary PE was 38.7±0.6 years and duration of suffer from PE was 15.8±0.4 years. We investigated the ejaculatory latency calculated by stop watch and sexual satisfaction rate after the treatment(1 placebo and 5 SS-cream 0.2gm). Patients were instructed to apply the cream on the glans penis 1 hour before sexual intercourse in double blind randomixzed fashion. Clinical efficacy was compared with the prolongation of ejaculatory latency and improvement of sexual satisfaction rate. Results : 106 patients with primary premature ejaculation completed this study. Mean ejaculatory latency tested at screening period was 1.37±0.1min and both of patient and partner were not satisfied with their sexual lives. The mean ejaculatory latency was significantly prolonged as 10.92±1.0min with SS-cream, while 2.45±0.3min with placebo. In 79.8%, there was prolongation of ejaculatory latency longer than 2 minutes with SS-cream, while in 15.1% with placebo. The sexual satisfaction rate was also significantly improved as 82.2% with SS-cream, while 12.6% with placebo. 103(16.2%) out of 636 trials of SS-cream showed mild local irritation including 82 mild burning senses and 21 mild pain, which disappeared in less than 1 hour. No adverse effect on sexual function and partner and no systemic side effects were observed. Conclusions : With these results, SS-cream is effective and safe in the treatment of PE with mild local side effect.