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

Phase 4

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

• Registration Number: NCT02344823
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-18
• Study First Posted: 2015-01-26
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Phase B	Placebo intake once daily	IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28
Vardenafil Phase A	HVPG (Hepatic venous pressure measurement) baseline	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
Placebo Phase A	HVPG (Hepatic venous pressure measurement) day 7	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
Vardenafil Phase A	HVPG (Hepatic venous pressure measurement) day 7	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
Vardenafil Phase A	IIEF 5 (International Index of Erectile Function) questionnaire at study phase end	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
Placebo Phase A	IIEF 5 (International Index of Erectile Function) questionaire baseline	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
Vardenafil Phase A	IIEF 5 (International Index of Erectile Function) questionaire baseline	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
Placebo Phase A	IIEF 5 (International Index of Erectile Function) questionnaire at study phase end	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
Vardenfil Phase B	Vardenafil	IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28
Vardenfil Phase B	IIEF 5 (International Index of Erectile Function) questionaire baseline	IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28
Vardenfil Phase B	IIEF 5 (International Index of Erectile Function) questionnaire at study phase end	IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28
Placebo Phase B	IIEF 5 (International Index of Erectile Function) questionnaire at study phase end	IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28
Vardenafil Phase A	Vardenafil	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
Placebo Phase A	HVPG (Hepatic venous pressure measurement) baseline	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
Placebo Phase A	Placebo intake once daily	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
Placebo Phase B	IIEF 5 (International Index of Erectile Function) questionaire baseline	IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna; 🇦🇹 Vienna, Austria