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

Phase 3

Withdrawn

• Conditions: Impotence

• Registration Number: NCT00382161
• Lead Sponsor: University Hospital, Saarland

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 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).

Study Timeline

• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Study Start: 2006-10
• Study Completion: 2007-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.
Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.

Trial Locations

Locations (1)

University Hospital of the Saarland; 🇩🇪 Homburg, Saarland, Germany