Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Placebo Phase B | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil | Drug | per oral intake of 10mg Vardenafil once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnulf Ferlitsch, MD | Contact | +4314040047410 | arnulf.ferlitsch@meduniwien.ac.at | |
| Remy Schwarzer, MD | Contact | +4314040047410 | remy.schwarzer@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Arnulf Ferlitsch, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
IIEF 5 (International Index of Erectile Function) at baseline and Response to Placebo per oral ad libidum in 28 days at day 28 |
|
| HVPG (Hepatic venous pressure measurement) baseline | Procedure | HVPG measurement day 1 |
|
|
| HVPG (Hepatic venous pressure measurement) day 7 | Procedure | HVPG measurement day 7 |
|
|
| IIEF 5 (International Index of Erectile Function) questionaire baseline | Behavioral | IIEF 5 questionaire to define level of erectile dysfunction at baseline |
|
|
| 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 |
|
|
| Placebo intake once daily | Drug |
|
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D007172 | Erectile Dysfunction |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| C074807 | BaseLine dental cement |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
Not provided
Not provided