Cirrhosis, Erectile Dysfunction
Conditions
Keywords
cirrhosis, erectile dysfunction, portal hypertension
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
Interventions
DRUGVardenafil
per oral intake of 10mg Vardenafil once daily
PROCEDUREHVPG (Hepatic venous pressure measurement) baseline
HVPG measurement day 1
PROCEDUREHVPG (Hepatic venous pressure measurement) day 7
HVPG measurement day 7
BEHAVIORALIIEF 5 (International Index of Erectile Function) questionaire baseline
IIEF 5 questionaire to define level of erectile dysfunction at baseline
BEHAVIORALIIEF 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
DRUGPlacebo intake once daily
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HVPG (Hepatic Venous Pressure Measurement) | 7 days | HVPG response to Vardenafil/Placebo at day 7 |
| IIEF (International Index of Erectile Function ) 5 | 28 days | IIEF 5 calculation after Vardenafil/Placebo both Phase A and B |
Countries
Austria
Contacts
Primary ContactArnulf Ferlitsch, MD
Backup ContactRemy Schwarzer, MD
Outcome results
None listed