Erectile dysfunction:a randomised controlled trial of lipid lowering with simvastatin (EDS trial) - Erectile dysfunctionand statins: a RCT (version 0.4)
- Conditions
- Erectile dysfunctionMedDRA version: 9.1Level: LLTClassification code 10061461Term: Erectile dysfunction
- Registration Number
- EUCTR2008-001579-32-GB
- Lead Sponsor
- niversity of Hertfordshire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
•Men aged 40 years and over
•In a stable heterosexual relationship for over 6 months
•No clinically overt cardiovascular risk factors other than raised cholesterol
•Not currently on lipid or ED therapy
•Untreated erectile dysfunction (ED) (score < 22 on the IIEF-5)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Diabetes, past history of myocardial infarction, hospitalised angina or
stroke
•Hypertension: systolic blood pressure > 170mmHg, diastolic > 100mmHg
•Ratio total:HDL cholesterol > 6.
•Total cardiovascular risk > 20% over next ten years
•Current lipid lowering therapy
•Current (within last 3 months) ED therapy
•Hypogonadism (Testosterone<8 nmol/L)
•Chronic liver disease
•Severe renal disease
•Inflammatory muscle disease or evidence of muscle problems
•Concomitant administration of contra-indicated drugs
•Concomitant administration of other drugs associated with increased risk of myopathy/rhabdomyolysis
•Other serious conditions at the discretion of the GP
•Unable to read and write in English.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method