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
- 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
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 Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
-
Contact:
- Arnulf Ferlitsch, MD
- Phone Number: 47410 +43140400
- Email: arnulf.ferlitsch@meduniwien.ac.at
-
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
|
per oral intake of 10mg Vardenafil once daily
HVPG measurement day 1
Other Names:
HVPG measurement day 7
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Other Names:
|
|
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
|
HVPG measurement day 1
Other Names:
HVPG measurement day 7
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Other Names:
|
|
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
|
per oral intake of 10mg Vardenafil once daily
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Other Names:
|
|
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
|
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Other Names:
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Other Names:
|
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
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
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Liver Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Fibrosis
- Liver Cirrhosis
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Vardenafil Dihydrochloride
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.