원발성 조루증 환자에서 SS-cream의 임상시험 평가
Clinical Study of SS-cream in Patients with Primary Premature Ejaculation
소속 상세정보
최형기/Hyung Ki Choi
정경우/문기학/신종성/최영득/이웅희/김동기/Gyung Woo Jung/Ki Hak Moon/Zhong Cheng Xin/Young Deuk Choi/Woong Hee Lee/Dong Ki Kim
KMID : 0358319990400040506
Abstract
결론
SS-cream의 조루증 치료에서 임상 유효성을 판정하기 위한 위약 대조, 무작위 배정, 이
중맹검으로 시행한 제 3상 임상 시험 결과 SS-cream의 사정잠복기와 성생활 만족도에 따
른 임상 유효성은 79.9%와 82.2%이었고 위약은 15.1%, 12.6%로 SS-cream의 임상 유효성은
위약에 비해 통계학적으로 유의하게 높은 것으로 판정되었다. SS-cream은 조루증 치료에서
전신적인 부작용 없이 안전하게 사용할 수 있는 국소 치료제로 생각된다.
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.
키워드
SS-cream; Premature ejaculation; Ejaculatory latency;
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