Clinical trial NCT00382161: Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
Official title: Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Impotence
Keywords: impotence
erectile dysfunction
cardiovascular risk factor
statin
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-09-28
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.
Secondary outcomes:
measure: Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.
measure: Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University Hospital of the Saarland
state: Saarland
Study officials:
affiliation: University Hospital of the Saarland
name: Magnus Baumhäkel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of the Saarland
name: Michael Böhm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of the Saarland
name: Martin Gerber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of the Saarland
name: Michael Stöckle, MD
role: PRINCIPAL_INVESTIGATOR
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