The effect of vardenafil, a new potent highly selective phosphodiesterase type 5 inhibitor in the treatment of erectile dysfunction
- VernacularTitle:伐地那非治疗勃起功能障碍的多中心、随机、双盲、对照研究
- Author:
Jie JIN
;
Zhanju HE
;
Kai ZHANG
;
Al ET
- Publication Type:Journal Article
- Keywords:
PDE5 inhibitor;
Vardenafil;
Erectile dysfunction;
Clinical research
- From:
Chinese Journal of Urology
2000;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the safety and efficacy of vardenafil,a novel selective phosphodiesterase type 5 inhibitor, in the treatment of male erectile dysfunction (ED). Methods This multicenter,randomized,double blind,placebo controlled study was performed at 7 domestic sites.A total of 624 men with mild to severe ED were enrolled in this trial of 4 weeks of washout and 12 weeks of treatment with either placebo or 5,10,20 mg of vardenafil on demand but not more than once a day. Results Analysis of safety and efficacy of vardenafil was performed on 602 cases who completed the trial.Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF).In the intent to treat population (n=602),the changes from baseline with 5,10,20 mg vardenafil groups were all improved ( P
