The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.
2 Phase 2 arm study Phase A: Baseline HVPG (Hepatic Venous Pressure Measurement) measurement, followed by 1 capsule of 10mg Vardenafil or Placebo (randomization 1:1) daily per oral for 7 days, HVPG measurement at day 7 Phase B: 1 capsule of 10mg Vardenafil or Placebo (randomization 1:1) ad libidum per oral for 28 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
per oral intake of 10mg Vardenafil once daily
HVPG measurement day 1
HVPG measurement day 7
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, Austria
RECRUITINGHVPG (Hepatic Venous Pressure Measurement)
HVPG response to Vardenafil/Placebo at day 7
Time frame: 7 days
IIEF (International Index of Erectile Function ) 5
IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
Time frame: 28 days
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IIEF 5 questionaire to define level of erectile dysfunction at baseline
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase