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

September 24, 2015 updated by: Arnulf Ferlitsch, MD, Medical University of Vienna
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Arnulf Ferlitsch, MD
        • Sub-Investigator:
          • Rémy Schwarzer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Vardenafil
per oral intake of 10mg Vardenafil once daily
Procedure: HVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
Other Names:
  • HVPG
Procedure: HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
Other Names:
  • HVPG
Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
  • IIEF 5
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
Other Names:
  • IIEF 5
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
Procedure: HVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
Other Names:
  • HVPG
Procedure: HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
Other Names:
  • HVPG
Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
  • IIEF 5
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
Other Names:
  • IIEF 5
Drug: Placebo intake once daily
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
Drug: Vardenafil
per oral intake of 10mg Vardenafil once daily
Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
  • IIEF 5
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
Other Names:
  • IIEF 5
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
Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
  • IIEF 5
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
Other Names:
  • IIEF 5
Drug: Placebo intake once daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Arnulf Ferlitsch, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 18, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT: 2010-023420-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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