Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02344823
Recruitment Status : Unknown
Verified September 2015 by Arnulf Ferlitsch, MD, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : January 26, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, 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.

Condition or disease Intervention/treatment Phase
Cirrhosis Erectile Dysfunction 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 Phase 4

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
Study Start Date : June 2012
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vardenafil

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 Name: HVPG

Procedure: HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
Other Name: HVPG

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Name: 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 Name: 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 Name: HVPG

Procedure: HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
Other Name: HVPG

Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: IIEF 5

Drug: Placebo intake once daily



Primary Outcome Measures :
  1. HVPG (Hepatic Venous Pressure Measurement) [ Time Frame: 7 days ]
    HVPG response to Vardenafil/Placebo at day 7

  2. IIEF (International Index of Erectile Function ) 5 [ Time Frame: 28 days ]
    IIEF 5 calculation after Vardenafil/Placebo both Phase A and B



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344823


Contacts
Layout table for location contacts
Contact: Arnulf Ferlitsch, MD +4314040047410 arnulf.ferlitsch@meduniwien.ac.at
Contact: Remy Schwarzer, MD +4314040047410 remy.schwarzer@meduniwien.ac.at

Locations
Layout table for location information
Austria
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Arnulf Ferlitsch, MD    +43140400 ext 47410    arnulf.ferlitsch@meduniwien.ac.at   
Principal Investigator: Arnulf Ferlitsch, MD         
Sub-Investigator: Rémy Schwarzer, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna

Layout table for additonal information
Responsible Party: Arnulf Ferlitsch, MD, Assoz. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02344823     History of Changes
Other Study ID Numbers: EUDRACT: 2010-023420-25
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Keywords provided by Arnulf Ferlitsch, MD, Medical University of Vienna:
cirrhosis
erectile dysfunction
portal hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Erectile Dysfunction
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents