Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HVPG (Hepatic Venous Pressure Measurement)
研究概览
简要总结
The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal hemodynamics in patients with liver cirrhosis.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Vardenafil (Drug)
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
干预措施: HVPG (Hepatic venous pressure measurement) baseline (Procedure)
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
干预措施: HVPG (Hepatic venous pressure measurement) day 7 (Procedure)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionaire baseline (Behavioral)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end (Behavioral)
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
干预措施: HVPG (Hepatic venous pressure measurement) baseline (Procedure)
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
干预措施: HVPG (Hepatic venous pressure measurement) day 7 (Procedure)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionaire baseline (Behavioral)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end (Behavioral)
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
干预措施: Placebo intake once daily (Drug)
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
干预措施: Vardenafil (Drug)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionaire baseline (Behavioral)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end (Behavioral)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionaire baseline (Behavioral)
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
干预措施: IIEF 5 (International Index of Erectile Function) questionnaire at study phase end (Behavioral)
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
干预措施: Placebo intake once daily (Drug)
结局指标
主要结局
HVPG (Hepatic Venous Pressure Measurement)
时间窗: 7 days
HVPG response to Vardenafil/Placebo at day 7
IIEF (International Index of Erectile Function ) 5
时间窗: 28 days
IIEF 5 calculation after Vardenafil/Placebo both Phase A and B
次要结局
未报告次要终点
研究者
Arnulf Ferlitsch, MD
Assoz. Prof. Dr.
Medical University of Vienna