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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02344823
• Other study ID #: EUDRACT: 2010-023420-25
• Status: Recruiting
• Phase: Phase 4
• First received: January 12, 2015
• Last updated: September 24, 2015
• Start date: June 2012

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: Arnulf Ferlitsch, MD
• Phone: +4314040047410
• Email: arnulf.ferlitsch[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Erectile Dysfunction
• Liver Cirrhosis

Intervention

Drug:
• Vardenafil
per oral intake of 10mg Vardenafil once daily

Procedure:
• HVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
• HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7

Behavioral:
• IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
• IIEF 5 (International Index of Erectile Function) questionnaire at study phase end
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase

Drug:
• Placebo intake once daily

Locations

Country	Name	City	State
Austria	Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HVPG (Hepatic Venous Pressure Measurement)	HVPG response to Vardenafil/Placebo at day 7	7 days	No
Primary	IIEF (International Index of Erectile Function ) 5	IIEF 5 calculation after Vardenafil/Placebo both Phase A and B	28 days	No