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

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

Detailed Description
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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

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

Conditions
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Cirrhosis, Erectile Dysfunction

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vardenafil Phase A<br>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 | Drug: Vardenafil<br>* per oral intake of 10mg Vardenafil once daily<br>Procedure: HVPG (Hepatic venous pressure measurement) baseline<br>* HVPG measurement day 1<br>* Other names: HVPG;Procedure: HVPG (Hepatic venous pressure measurement) day 7<br>* HVPG measurement day 7<br>* Other names: HVPG;Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline<br>* IIEF 5 questionaire to define level of erectile dysfunction at baseline<br>* Other names: IIEF 5;Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end<br>* IIEF 5 questionaire to define level of erectile dysfunction at end of study phase<br>* Other names: IIEF 5;|
| Placebo Comparator: Placebo Phase A<br>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 | Procedure: HVPG (Hepatic venous pressure measurement) baseline<br>* HVPG measurement day 1<br>* Other names: HVPG;Procedure: HVPG (Hepatic venous pressure measurement) day 7<br>* HVPG measurement day 7<br>* Other names: HVPG;Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline<br>* IIEF 5 questionaire to define level of erectile dysfunction at baseline<br>* Other names: IIEF 5;Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end<br>* IIEF 5 questionaire to define level of erectile dysfunction at end of study phase<br>* Other names: IIEF 5;Drug: Placebo intake once daily<br> <br> |
| Active Comparator: Vardenfil Phase B<br>IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28 | Drug: Vardenafil<br>* per oral intake of 10mg Vardenafil once daily<br>Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline<br>* IIEF 5 questionaire to define level of erectile dysfunction at baseline<br>* Other names: IIEF 5;Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end<br>* IIEF 5 questionaire to define level of erectile dysfunction at end of study phase<br>* Other names: IIEF 5;|
| Placebo Comparator: Placebo Phase B<br>IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28 | Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline<br>* IIEF 5 questionaire to define level of erectile dysfunction at baseline<br>* Other names: IIEF 5;Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end<br>* IIEF 5 questionaire to define level of erectile dysfunction at end of study phase<br>* Other names: IIEF 5;Drug: Placebo intake once daily<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HVPG (Hepatic Venous Pressure Measurement) | HVPG response to Vardenafil/Placebo at day 7 | 7 days | 
| IIEF (International Index of Erectile Function ) 5 | IIEF 5 calculation after Vardenafil/Placebo both Phase A and B | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, erectile dysfunction, portal hypertension