Protocol for a study on male patients suffering from peripheral arterial disease with severe chronic limb ischemia during treatment with iloprost: assessment of oxidative stress and organic erectile dysfunction - ND
- Conditions
- peripheral arterial disease and organic erectile dysfunction.MedDRA version: 9.1Level: SOCClassification code 10047065Term: Vascular disorders
- Registration Number
- EUCTR2008-006304-38-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Sex: male
Married
Peripheral arterial disease not eligible for revascularization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Eligibility for revascularization
Inflammatory diseases
Cancer
Obesity
Intolerance to the drug (iloprost)
Haemorrhagic risk: peptic ulcer, trauma, cerebral haemorrhage
Acute or chronic cardiac failure (NYHA II-IV)
Severe coronary artery disease or unstable angina
Myocardial infarction in the previous six months
Severe arrhythmias
Suspicion of pulmonary congestion
Current use of antioxidant drugs
Smoking
Current use of beta-blockers, clonidine, alphamethyldopa and major analgesic drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the variation of oxidative stress (hydroperoxide blood level) and of erectile dysfunction in patients affected by peripheral arterial disease, not eligible for revascularization, during treatment with iloprost.;Secondary Objective: nd;Primary end point(s): nd
- Secondary Outcome Measures
Name Time Method