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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006304-38-IT
Enrollment
Unknown
Registered
2008-11-20
Start date
2008-12-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral arterial disease and organic erectile dysfunction. MedDRA version: 9.1 Level: SOC Classification code 10047065 Term: Vascular disorders

Interventions

Trade Name: ENDOPROST Pharmaceutical Form: Solution for infusion INN or Proposed INN: Iloprost Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .05-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026