[Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction].
OBJECTIVE
To evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies.


METHODS
A total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil.


RESULTS
This study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo.


CONCLUSIONS
Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.
Pan
Tianming
T
Department of Urology, the Third Hospital of Peking University, Beijing 100083, China.
Zhuang
Shenrong
S
Ma
Hongming
H
Hong
Kai
K
Tang
Wenhao
W
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride