Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
NCT ID: NCT02344823
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2012-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Vardenafil
per oral intake of 10mg Vardenafil once daily
HVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
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
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 (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
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
Placebo intake once daily
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
Vardenafil
per oral intake of 10mg Vardenafil once daily
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
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 (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
Placebo intake once daily
Interventions
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Vardenafil
per oral intake of 10mg Vardenafil once daily
HVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
HVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
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
Placebo intake once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \> 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
18 Years
MALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Arnulf Ferlitsch, MD
Assoz. Prof. Dr.
Principal Investigators
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Arnulf Ferlitsch, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EUDRACT: 2010-023420-25
Identifier Type: -
Identifier Source: org_study_id
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