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

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: Erectile Dysfunction; Cirrhosis

Treatments: Procedure: HVPG (Hepatic venous pressure measurement) day 7; Drug: Placebo intake once daily; Drug: Vardenafil; Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline; Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end; Procedure: HVPG (Hepatic venous pressure measurement) baseline

Study type: Interventional

Funder types: Other

Identifiers

NCT02344823

EUDRACT: 2010-023420-25

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Vardenafil Phase A

Active Comparator group

Description:

HVPG (Hepatic Venous Pressure Measurement) at baseline and Response to Vardenafil 10mg per oral for 7 days at day 7 IIEF5 at baseline and day 7

Treatment:

Procedure: HVPG (Hepatic venous pressure measurement) baseline

Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline

Procedure: HVPG (Hepatic venous pressure measurement) day 7

Drug: Vardenafil

Placebo Phase A

Placebo Comparator group

Description:

HVPG (Hepatic Venous Pressure Measurement) Measurement at baseline and Response to Placebo per oral for 7 days at day 7 IIEF 5 at baseline and day 7

Treatment:

Procedure: HVPG (Hepatic venous pressure measurement) baseline

Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline

Procedure: HVPG (Hepatic venous pressure measurement) day 7

Drug: Placebo intake once daily

Vardenfil Phase B

Active Comparator group

Description:

IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28

Treatment:

Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline

Drug: Vardenafil

Placebo Phase B

Placebo Comparator group

Description:

IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28

Treatment:

Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline

Drug: Placebo intake once daily