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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Vardenafil Dihydrochloride

Criteria

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