Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT00382161
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00382161
Study Brief:
Protocol Section:
NCT00382161