[Efficacy and safety of PGE1 cream in the treatment of erectile dysfunction].

Abstract

OBJECTIVES:

To evaluate the efficacy and safety of PGE1 cream[Befar, NexMed Pharmaceuticals(Zhongshan) Ltd] on men with ED of various etiologies in China.

METHODS:

This was a double-blind, randomized (1:1, placebo: PGE1 cream), placebo-controlled clinic study of PGE1 cream performed at Peking University Pepole's Hospital for 8 weeks. A total of 42 subjects suffered from erectile dysfunction of psychologic, organic or mixed etiology were screened and randomized, and visited occurred at weeks -4, 0, 2 and 4 weeks covering a 4-week no treatment run-in period and a 4-week period of double blind treatment.

RESULTS:

At week four PGE1 cream was shown to be significantly (P < 0.01) effective over placebo in the sexual function endpoints analyses. The primary efficacy variables (Questions 3 and 4 from IIEF) revealed a statistically significant (P < 0.01) improvement over placebo along with a clinical efficacy change score with an effective rate of 63.16% on PGE1 cream vs 9.52% on placebo. The secondary efficacy variables supported the conclusion of the primary efficacy (assessing the proportion of successful attempts at sexual intercourse 68.42% on PGE1 cream vs 19.05% on placebo), and the global assessment question (treatment had improved their erections, 73.68% on PGE1 cream vs 19.05% on placebo). PGE1 cream was well tolerated when given prn. Subjects in the study had a low discontinuation rate (4.76%), only one subject (2.38%) discontinued due to adverse events. The incidence of adverse events was higher for PGE1 cream (30.00%) than for placebo (4.76%). The common adverse events were mild pain of penis and urethra.

CONCLUSIONS:

PGE1 cream is an effective, safe and well-tolerated treatment in subjects with erectile dysfunction of organic, psychologic or mixed etiology.

• Authors: Hui Jiang, Qing-Quan Xu, Kai Hong, Xiao-Feng Wang, Ji-Chuan Zhu
• Journal: Zhonghua nan ke xue = National journal of andrology (Zhonghua Nan Ke Xue) Vol. 9 Issue 2 Pg. 97-9 (Apr 2003) ISSN: 1009-3591 [Print] China
• PMID: 12749125 (Publication Type: Clinical Trial, English Abstract, Journal Article, Randomized Controlled Trial)

Chemical References

• Vasodilator Agents
• Alprostadil

Topics

• Adult
• Aged
• Alprostadil (adverse effects, therapeutic use)
• Double-Blind Method
• Erectile Dysfunction (drug therapy)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Vasodilator Agents (adverse effects, therapeutic use)