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

Choi, Hyung Ki; Jung, Gyung Woo; Moon, Ki Hak; Xin, Zhong Cheng; Choi, Young Deuk; Lee, Woong Hee; Kim, Dong Ki

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.