Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors

• Status: Withdrawn
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Saarland
• Collaborator: Novartis
• Treatments: Fluvastatin

Criteria

Inclusion Criteria:

• male

• age > 18 years

• arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity<30cm/s, diastolic velocity<5cm/s)

• two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a HbA1c<7%)

• stable course of disease without expected changes in medical treatment during the next 3 months

• written informed consent

• no statin-treatment so far

Exclusion Criteria:

• known hypersensitivity or anaphylaxis against a statin

• active liver disease or unclear increase of transaminases, cholestasis or myopathy

• acute cardiovascular event (myocardial infarction, stroke, PTCA, vascular surgery) within 3 months before randomization

• clinical signs of heart failure or reduced left ventricular function

• current treatment with lipid lowering drugs

• insulin dependent diabetes mellitus or orally treated diabetes mellitus with a HbA1c-value >6.9%

• erectile dysfunction due to hormone disorders

• known malignant tumor

• known disposition to priapism

• patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis

• current treatment with anticoagulants

• current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates

• absence or inability of written informed consent