[Efficacy and safety of PGE1 cream in the treatment of erectile dysfunction].
OBJECTIVE
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.
Jiang
Hui
H
Department of Urology and Andrology, Peking University People's Hospital, Beijing 100044, China.
Xu
Qing-Quan
QQ
Hong
Kai
K
Wang
Xiao-Feng
XF
Zhu
Ji-Chuan
JC
D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D014665:Vasodilator Agents; D000527:Alprostadil