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

University Hospital, Saarland

Status and phase

Withdrawn

Phase 3

Conditions

Impotence

Treatments

Drug: Fluvastatin-sodium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00382161

EudraCT-No.:2006-000284-28

48/05

Details and patient eligibility

About

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.

Full 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 endothelial function. Thus, activation of endothelial NO-synthase could raise the activation of guanylate-cyclase with a consecutive relaxation of smooth muscle cells in the penile arteries and the corpus cavernosum leading to an improvement of erectile function. Therefore, statins are supposed to be effective in the treatment of erectile dysfunction, especially in patients with cardiovascular risk-factors with underlying endothelial dysfunction.

The effect of fluvastatin on penile blood-flow and erectile function in patients with arteriogenic erectile dysfunction and cardiovascular risk factors will be determined in a cross-over design. Patients were either treated with fluvastatin-sodium 80mg or placebo for 8 weeks. After a wash-out of 4 weeks, treatment will be switched (placebo / fluvastatin-sodium). Penile blood flow measurement and assessment of erectile function with the IIEF-5-score and the KEED-score will be performed at baseline, after 8 weeks of treatment, after 4 weeks wash-out and after cross-over treatment (8 weeks).

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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