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

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ClinicalTrials.gov Identifier: NCT02344823
Recruitment Status : Unknown
Verified September 2015 by Arnulf Ferlitsch, MD, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : January 26, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Arnulf Ferlitsch, MD, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date September 25, 2015
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2015)
  • HVPG (Hepatic Venous Pressure Measurement) [ Time Frame: 7 days ]
    HVPG response to Vardenafil/Placebo at day 7
  • IIEF (International Index of Erectile Function ) 5 [ Time Frame: 28 days ]
    IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
Official Title  ICMJE Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cirrhosis
  • Erectile Dysfunction
Intervention  ICMJE
  • Drug: Vardenafil
    per oral intake of 10mg Vardenafil once daily
  • Procedure: HVPG (Hepatic venous pressure measurement) baseline
    HVPG measurement day 1
    Other Name: HVPG
  • Procedure: HVPG (Hepatic venous pressure measurement) day 7
    HVPG measurement day 7
    Other Name: HVPG
  • Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline
    IIEF 5 questionaire to define level of erectile dysfunction at baseline
    Other Name: IIEF 5
  • Behavioral: 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
    Other Name: IIEF 5
  • Drug: Placebo intake once daily
Study Arms  ICMJE
  • 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
    Interventions:
    • 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 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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 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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 18, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344823
Other Study ID Numbers  ICMJE EUDRACT: 2010-023420-25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arnulf Ferlitsch, MD, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP