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

NCT02344823 | Unknown Phase 4 DMC

• 1 other identifier: EUDRACT: 2010-023420-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.

Conditions

Cirrhosis; Erectile Dysfunction

Keywords

cirrhosis; erectile dysfunction; portal hypertension

Outcome Measures

Primary Outcomes (2)

• HVPG (Hepatic Venous Pressure Measurement)

  HVPG response to Vardenafil/Placebo at day 7

  7 days

• IIEF (International Index of Erectile Function ) 5

  IIEF 5 calculation after Vardenafil/Placebo both Phase A and B

  28 days

Study Arms (4)

Vardenafil Phase A

ACTIVE COMPARATOR

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; 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

Placebo Phase A

PLACEBO COMPARATOR

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; 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

Vardenfil Phase B

ACTIVE COMPARATOR

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; Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline; Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end

Placebo Phase B

PLACEBO COMPARATOR

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; Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end; Drug: Placebo intake once daily

Interventions

Vardenafil DRUG

per oral intake of 10mg Vardenafil once daily

Vardenafil Phase A; Vardenfil Phase B

HVPG (Hepatic venous pressure measurement) baseline PROCEDURE

HVPG measurement day 1

Also known as: HVPG

Placebo Phase A; Vardenafil Phase A

HVPG (Hepatic venous pressure measurement) day 7 PROCEDURE

HVPG measurement day 7

Also known as: HVPG

Placebo Phase A; Vardenafil Phase A

IIEF 5 (International Index of Erectile Function) questionaire baseline BEHAVIORAL

IIEF 5 questionaire to define level of erectile dysfunction at baseline

Also known as: IIEF 5

Placebo Phase A; Placebo Phase B; Vardenafil Phase A; Vardenfil Phase B

IIEF 5 (International Index of Erectile Function) questionnaire at study phase end BEHAVIORAL

IIEF 5 questionaire to define level of erectile dysfunction at end of study phase

Also known as: IIEF 5

Placebo Phase A; Placebo Phase B; Vardenafil Phase A; Vardenfil Phase B

Placebo intake once daily DRUG

Placebo Phase A; Placebo Phase B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cardiac, renal or respiratory failure
• previous surgical or transjugular intrahepatic portosystemic shunt
• insulin-dependent diabetes
• Child´s Grade C cirrhosis

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Fibrosis; Erectile Dysfunction; Hypertension, Portal

Interventions

Vardenafil Dihydrochloride; BaseLine dental cement

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Arnulf Ferlitsch, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnulf Ferlitsch, MD

CONTACT

+4314040047410; arnulf.ferlitsch@meduniwien.ac.at

Remy Schwarzer, MD

CONTACT

+4314040047410; remy.schwarzer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoz. Prof. Dr.

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 26, 2015
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

AU (1)