Status:
WITHDRAWN
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
Lead Sponsor:
University Hospital, Saarland
Collaborating Sponsors:
Novartis
Conditions:
Impotence
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Physiology of erection is mainly dependent on endothelial NO-production with consecutive activation of guanylate-cyclase. Pleiotropic effects of statins are well known regarding the increase of endoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00382161
Start Date
October 1 2006
End Date
December 1 2007
Last Update
February 13 2009
Active Locations (1)
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1
University Hospital of the Saarland
Homburg, Saarland, Germany, 66421