CirrhosisPhase 4NCT02344823
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
A Phase 4 study testing Vardenafil, HVPG (Hepatic venous pressure measurement) baseline and HVPG (Hepatic venous pressure measurement) day 7 in people with Cirrhosis and Erectile Dysfunction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cirrhosis, Erectile Dysfunction
- What is being tested?
- Vardenafil, HVPG (Hepatic venous pressure measurement) baseline and HVPG (Hepatic venous pressure measurement) day 7
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Cardiac, renal or respiratory failure
- previous surgical or transjugular intrahepatic portosystemic shunt
- insulin-dependent diabetes
- Child´s Grade C cirrhosis
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, 1090
Arnulf Ferlitsch, MD, +43140400 ext. 47410, arnulf.ferlitsch@meduniwien.ac.at
Arnulf Ferlitsch, MD
About this study
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.
Read the 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
- Conditions
- Cirrhosis, Erectile Dysfunction
- Being tested
- 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
- Keywords
- cirrhosis, erectile dysfunction, portal hypertension
- Medical subject headings
- Fibrosis, Erectile Dysfunction, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
per oral intake of 10mg Vardenafil once daily
HVPG (Hepatic venous pressure measurement) baselineProcedure or surgery
Also called HVPG
HVPG measurement day 1
HVPG (Hepatic venous pressure measurement) day 7Procedure or surgery
Also called HVPG
HVPG measurement day 7
IIEF 5 (International Index of Erectile Function) questionaire baselineBehavioural
Also called IIEF 5
IIEF 5 questionaire to define level of erectile dysfunction at baseline
IIEF 5 (International Index of Erectile Function) questionnaire at study phase endBehavioural
Also called IIEF 5
IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
Placebo intake once dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HVPG (Hepatic Venous Pressure Measurement)
HVPG response to Vardenafil/Placebo at day 7
Measured: 7 days
IIEF (International Index of Erectile Function ) 5
IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnulf Ferlitsch, MD, Medical University of Vienna
- Investigators
- Arnulf Ferlitsch, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344823
- Sponsor's protocol ID
- EUDRACT: 2010-023420-25
- Status last verified
- Sep 2015
- First submitted
- 12 Jan 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02344823
- Acronym / sponsor ID
- EUDRACT: 2010-023420-25
- Conditions
- Cirrhosis, Erectile Dysfunction
- Keywords
- cirrhosis, erectile dysfunction, portal hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vardenafil Phase A | Active comparator | 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 endHVPG (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 |
| Placebo Phase A | Placebo comparator | 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 dailyHVPG (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 |
| Vardenfil Phase B | Active comparator | Drug: Vardenafil, Behavioral: IIEF 5 (International Index of Erectile Function) questionaire baseline, Behavioral: IIEF 5 (International Index of Erectile Function) questionnaire at study phase endIIEF 5 (International Index of Erectile Function) at baseline and Response to Vardenafil 10mg per oral ad libidum in 28 days at day 28 |
| Placebo Phase B | Placebo comparator | 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 dailyIIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vardenafilper oral intake of 10mg Vardenafil once daily | Drug | Vardenafil Phase A, Vardenfil Phase B |
| HVPG (Hepatic venous pressure measurement) baselineAlso: HVPGHVPG measurement day 1 | Procedure or surgery | Placebo Phase A, Vardenafil Phase A |
| HVPG (Hepatic venous pressure measurement) day 7Also: HVPGHVPG measurement day 7 | Procedure or surgery | Placebo Phase A, Vardenafil Phase A |
| IIEF 5 (International Index of Erectile Function) questionaire baselineAlso: IIEF 5IIEF 5 questionaire to define level of erectile dysfunction at baseline | Behavioural | Placebo Phase A, Placebo Phase B, Vardenafil Phase A, Vardenfil Phase B |
| IIEF 5 (International Index of Erectile Function) questionnaire at study phase endAlso: IIEF 5IIEF 5 questionaire to define level of erectile dysfunction at end of study phase | Behavioural | Placebo Phase A, Placebo Phase B, Vardenafil Phase A, Vardenfil Phase B |
| Placebo intake once daily | Drug | Placebo Phase A, Placebo Phase B |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnulf Ferlitsch, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vardenafil, HVPG (Hepatic venous pressure measurement) baseline and HVPG (Hepatic venous pressure measurement) day 7 in people with Cirrhosis and Erectile Dysfunction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnulf Ferlitsch, MD (+4314040047410, arnulf.ferlitsch@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HVPG (Hepatic Venous Pressure Measurement) (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.