These efficacy variables appeared greater at higher doses , although there are no significant differences between 10 and 20 mg dose .
Specific adverse events with vardenafil  included flushing , dyspepsia , headache , and rhinitis .
Vardenafil was not significantly associated with serious cardiovascular events or death .
Vardenafil , in all treatment regimens , shows to possess superior efficacy to placebo in the treatment of patients with erectile dysfunction .
Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study
Abstract The pharmacodynamic effect on penile rigidity and tumescence and the pharmacokinetic properties of single oral doses of 10 and 20 mg vardenafil , a new PDE5-inhibitor , were investigated in 21 erectile dysfunction patients . Patients were evaluated with RigiScan on three occasions in a r and omized , placebo-controlled , double-blind crossover fashion , while receiving visual sexual stimulation . Relative to placebo , a single dose of 10 mg vardenafil led to a mean increase in the duration of > 60 % penile rigidity of 24.4 min ( 95 % CI : 7.4 to 41.3 ) at the base and of 24.8 min ( 8.5 to 41.1 ) at the tip . For the 20-mg dose , the increase in duration of > 60 % penile rigidity relative to placebo was 37.2 min ( 20.2 to 54.1 ) at the base and 28.7 min ( 12.7 to 44.7 ) at the tip . Single doses of 10 and 20 mg vardenafil led to a rapid rise in the plasma concentrations of vardenafil , with a median tmax of 0.9 h and 0.7 h and a geometric mean Cmax of 9.1 μg/l ( geometric SD=1.63 ) and 20.9 μg/l ( geometric SD=1.83 ) , respectively . In the post-absorptive phase , the concentrations declined with an average terminal t1/2 of 4.2 h ( geometric SD=1.27 ) and 3.9 h ( geometric SD=1.31 ) . The systemic exposure  of vardenafil expressed as AUC normalized for dose and body weight was dose-proportional ( associated 90 % CI : −4 to 30 % ) as well as Cmax ( associated 90 % CI : −12 to 33 % ) . The treatments were well tolerated . There was a small , clinical ly irrelevant reduction in blood pressure with a small compensatory rise in heart rate . There were no electrocardiographic effects or relevant changes of the safety laboratory screens . The observed pro-erectile properties , pharmacokinetic characteristics and safety profile make vardenafil a suitable c and i date for further evaluation in the treatment of erectile dysfunction
These efficacy variables appeared greater at higher doses , although there are no significant differences between 10 and 20 mg dose .
Specific adverse events with vardenafil  included flushing , dyspepsia , headache , and rhinitis .
Vardenafil was not significantly associated with serious cardiovascular events or death .
Vardenafil , in all treatment regimens , shows to possess superior efficacy to placebo in the treatment of patients with erectile dysfunction .