[Efficacy and safety of PGE1 cream in the treatment of erectile dysfunction]. [Article in Chinese]
Author(s): Jiang H, Xu QQ, Hong K, Wang XF, Zhu JC.
Affiliation(s): Department of Urology and Andrology, Peking University People's Hospital, Beijing
100044, China.
Publication date & source: 2003, Zhonghua Nan Ke Xue. , 9(2):97-9
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.
|