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Safety and efficacy study with various doses of SS-cream in patients with premature ejaculation in a double-blind, randomized, placebo controlled clinical study

Authors
 HK Choi  ;  ZC Xin  ;  YD Choi  ;  WH Lee  ;  SY Mah  ;  DK Kim 
Citation
 International Journal of Impotence Research, Vol.11(5) : 261-265, 1999 
Journal Title
 International Journal of Impotence Research 
ISSN
 0955-9930 
Issue Date
1999
MeSH
Administration, Topical ; Adult ; Double-Blind Method ; Ejaculation ; Humans ; Logistic Models ; Male ; Panax ; Placebos ; Plant Extracts/administration & dosage ; Plant Extracts/adverse effects ; Plant Extracts/therapeutic use* ; Plants, Medicinal* ; Sexual Dysfunction, Physiological/drug therapy* ; Time Factors
Abstract
OBJECTIVES: SS-cream is a topical agent made from the extracts of natural products for treating premature ejaculation (PE). To determine the optimal clinical dosage of SS-cream on PE, we investigated the safety and efficacy of SS-cream with various doses. A double blind, randomized placebo controlled clinical study was performed. METHODS: Fifty patients completed the study. Mean age of the patients was 37.1+/-1.O y and mean ejaculatory latency was 1.35+/-0.07 min. Sexual satisfaction rate of both the partner and patient was 16.2%. Each patient was instructed to apply the different cream (placebo, SS-cream 0.05, 0.10, 0.15, 0.20 g) on glans penis 1 h before sexual intercourse in random fashion. The ejaculatory latency was measured by stop watch and the satisfaction rate of both partner and patient was also recorded two times in the screening period and after the application of each test drugs. Clinical efficacy was considered if ejaculatory latency was prolonged more than 2 min and sexual satisfaction rate increased more than 20% than that of pretest values. RESULTS: The mean ejaculatory latencies were significantly prolonged after using various test drugs (placebo 2.27+/-0.32, SS-cream 0.05 g 4.47+/-0.81, 0.10 g 5.34+/-0.79, 0.15 g 6.22+/-0.87, 0.20 g 11.06+/-1.17 min, respectively). Clinical efficacies evaluated by ejaculatory latency were placebo 18%, SS-cream 0.05 g 30%, 0.10 g 60%, 0.15 g 54%, 0.20 g 84%, respectively. The satisfaction rate was also significantly increased dose-dependently (placebo 26%, SS-cream 0.05 g 60%, 0.10 g 70%, 0.15 g 78%, 0.20 g 90%, respectively). A side effect such as local mild burning sensation was noted in 35/250 times (14%) and no adverse effect on sexual function and no systemic side effects were observed. From the result of logistic regression analysis on clinical efficacy, the ED50 of SS-cream was obtained as 0.10 g. SS-cream 0.20 g was effective in 84% without any serious systemic side effects. CONCLUSION: From the above results, our conclusions are that SS-cream is effective on the treatment of PE with a few local side effects and that clinical optimal dose of SS-cream is 0.20 g.
Files in This Item:
T199903254.pdf Download
DOI
10.1038/sj.ijir.3900431
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Choi, Young Deuk(최영득) ORCID logo https://orcid.org/0000-0002-8545-5797
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/174314
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