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Clinical study of SS-cream in patients with lifelong premature ejaculation.

Abstract：

OBJECTIVES:To investigate the clinical efficacy of SS-cream, the topical agent made from the extracts of nine natural products for the treatment of premature ejaculation, we performed a double-blind, randomized, placebo-controlled Phase III clinical study of patients with lifelong premature ejaculation in three medical centers. METHODS:One hundred six patients (mean age 38.7 +/- 0.61 years) completed this study. The ejaculatory latency measured by stopwatch and sexual satisfaction ratio of both partner and patient were investigated twice in the screening period and once after each treatment (1 placebo 0.20 g and 5 SS-cream 0.20 g for a total of six treatments). Patients were instructed to apply the cream on the glans penis 1 hour before sexual intercourse in a double-blind randomized fashion. Clinical efficacy was compared with the prolongation of ejaculatory latency and improvement of the sexual satisfaction ratio before and after each treatment. RESULTS:In the screening period, the mean ejaculatory latency was assessed at 1.37 +/- 0.12 minutes, and neither the patients nor their partners were satisfied with their sexual lives. After treatment, the mean ejaculatory latency was prolonged to 2.45 +/- 0.29 minutes in the placebo group and 10.92 +/- 0.95 minutes in the SS-cream group. The clinical efficacy of placebo and SS-cream as judged by an ejaculatory latency time prolonged more than 2 minutes was 15.09% and 79.81%, respectively. The improvement of sexual satisfaction to a grade higher than effective was 19.81% and 82.19%, respectively, for placebo and SS-cream. Of 530 trials of SS-cream, 98 (18.49%) resulted in a sense of mild local burning and mild pain. No adverse effect on sexual function or partner and no systemic side effects were observed. CONCLUSIONS:According to these results, SS-cream is effective and safe in the treatment of premature ejaculation, with mild local side effects.

journal_name

Urology

journal_title

Urology

authors

Choi HK,Jung GW,Moon KH,Xin ZC,Choi YD,Lee WH,Rha KH,Choi YJ,Kim DK

doi

10.1016/s0090-4295(99)00415-x

subject

Has Abstract

pub_date

2000-02-01 00:00:00

pages

257-61

issue

2

eissn

0090-4295

issn

1527-9995

pii

S0090-4295(99)00415-X

journal_volume

55

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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