Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis

Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis

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

Inclusion Criteria:

• Male patients aged older than 18 years with mild to moderate (Child´s Grade A or B) cirrhosis scheduled for hepatic hemodynamic investigation.
• Erectile dysfunction in medical history
• Following beta-blocker therapy will be allowed: carvedilol (up to the max. dose of 25 mg) and propranolol (up to the max. dose of 160 mg)
• Patient living in a stable relationship
• HVPG (Hepatic Venous Pressure Measurement)>= 10 mmHg

Exclusion Criteria:

• HVPG <10
• HVPG > 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months
• history of variceal bleeding without secondary prophylaxis with beta blocker or endoscopic band ligation
• History of endoscopically diagnosed large varices with red spots without previous bleeding and without prophylactic beta blocker or endoscopic band ligation
• History of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure
• Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study
• Exclusion criteras for hepatic hemodynamic investigation
• Cardiac, renal or respiratory failure
• previous surgical or transjugular intrahepatic portosystemic shunt
• insulin-dependent diabetes
• Child´s Grade C cirrhosis