Clinical Study of SS-cream in Patients with Primary Premature Ejaculation / 대한비뇨기과학회지

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 randomized 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+/-0.1 min and both of patient and partner were not satisfied with their sexual lives. The mean ejaculatory latency was significantly prolonged as 10.92+/-1.0 min with SS-cream, while 2.45+/-0.3 min 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 PE with mild local side effect.