Back to resultsEffect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
Primary Purpose
Cirrhosis, Erectile Dysfunction
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Vardenafil
HVPG (Hepatic venous pressure measurement) baseline
HVPG (Hepatic venous pressure measurement) day 7
IIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 (International Index of Erectile Function) questionnaire at study phase end
Placebo intake once daily
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis, erectile dysfunction, portal hypertension
Eligibility 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
Sites / Locations
- Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Vardenafil Phase A
Placebo Phase A
Vardenfil Phase B
Placebo Phase B
Arm Description
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
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
IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28
IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28
Outcomes
Primary Outcome Measures
HVPG (Hepatic Venous Pressure Measurement)
HVPG response to Vardenafil/Placebo at day 7
IIEF (International Index of Erectile Function ) 5
IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
Secondary Outcome Measures
Full Information
NCT ID
NCT02344823
First Posted
January 12, 2015
Last Updated
September 24, 2015
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02344823
Brief Title
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
Official Title
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Erectile Dysfunction
Keywords
cirrhosis, erectile dysfunction, portal hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vardenafil Phase A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Phase A
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Vardenfil Phase B
Arm Type
Active Comparator
Arm Description
IIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28
Arm Title
Placebo Phase B
Arm Type
Placebo Comparator
Arm Description
IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28
Intervention Type
Drug
Intervention Name(s)
Vardenafil
Intervention Description
per oral intake of 10mg Vardenafil once daily
Intervention Type
Procedure
Intervention Name(s)
HVPG (Hepatic venous pressure measurement) baseline
Other Intervention Name(s)
HVPG
Intervention Description
HVPG measurement day 1
Intervention Type
Procedure
Intervention Name(s)
HVPG (Hepatic venous pressure measurement) day 7
Other Intervention Name(s)
HVPG
Intervention Description
HVPG measurement day 7
Intervention Type
Behavioral
Intervention Name(s)
IIEF 5 (International Index of Erectile Function) questionaire baseline
Other Intervention Name(s)
IIEF 5
Intervention Description
IIEF 5 questionaire to define level of erectile dysfunction at baseline
Intervention Type
Behavioral
Intervention Name(s)
IIEF 5 (International Index of Erectile Function) questionnaire at study phase end
Other Intervention Name(s)
IIEF 5
Intervention Description
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Intervention Type
Drug
Intervention Name(s)
Placebo intake once daily
Primary Outcome Measure Information:
Title
HVPG (Hepatic Venous Pressure Measurement)
Description
HVPG response to Vardenafil/Placebo at day 7
Time Frame
7 days
Title
IIEF (International Index of Erectile Function ) 5
Description
IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
Time Frame
28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnulf Ferlitsch, MD
Phone
+4314040047410
Email
arnulf.ferlitsch@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Remy Schwarzer, MD
Phone
+4314040047410
Email
remy.schwarzer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
Phone
+43140400
Ext
47410
Email
arnulf.ferlitsch@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
First Name & Middle Initial & Last Name & Degree
Rémy Schwarzer, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
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