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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2016

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

Interventions

  • Drug: Vardenafil
    • per oral intake of 10mg Vardenafil once daily
  • Procedure: HVPG (Hepatic venous pressure measurement) baseline
    • HVPG measurement day 1
  • Procedure: 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
  • Behavioral: 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

Arms, Groups and Cohorts

  • Active Comparator: Vardenafil Phase A
    • 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 Comparator: Placebo Phase A
    • 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
  • Active Comparator: Vardenfil Phase B
    • 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 Comparator: Placebo Phase B
    • IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arnulf Ferlitsch, MD, Assoz. Prof. Dr. – Medical University of Vienna
  • Overall Official(s)
    • Arnulf Ferlitsch, MD, Principal Investigator, Medical University of Vienna
  • Overall Contact(s)
    • Arnulf Ferlitsch, MD, +4314040047410, arnulf.ferlitsch@meduniwien.ac.at

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.