Efficacy and safety of PGE1 cream in the treatment of erectile dysfunction / 中华男科学杂志
National Journal of Andrology
; (12): 97-99, 2003.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-322540
Responsible library:
WPRO
ABSTRACT
<p><b>OBJECTIVES</b>To evaluate the efficacy and safety of PGE1 cream[Befar, NexMed Pharmaceuticals(Zhongshan) Ltd] on men with ED of various etiologies in China.</p><p><b>METHODS</b>This was a double-blind, randomized (11, 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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>PGE1 cream is an effective, safe and well-tolerated treatment in subjects with erectile dysfunction of organic, psychologic or mixed etiology.</p>
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Vasodilator Agents
/
Alprostadil
/
Double-Blind Method
/
Treatment Outcome
/
Therapeutic Uses
/
Drug Therapy
/
Erectile Dysfunction
Type of study:
Controlled clinical trial
Limits:
Adult
/
Aged
/
Humans
/
Male
Language:
Chinese
Journal:
National Journal of Andrology
Year:
2003
Document type:
Article