Erectile dysfunction MedDRA version: 9.1 Level: LLT Classification code 10061461 Term: Erectile dysfunction
Conditions
Interventions
Trade Name: Zocor
Product Name: Simvastatin
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
University of Hertfordshire
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether, in men with untreated ED but no other cardiovascular risk factors, not currently receiving lipid lowering therapy, treatment with Simvastatin improves erectile function.;Secondary Objective: To determine whether: 1) Any improvement in erectile function leads to an improvement in sexual health related quality of life. 2) Any improvement in erectile function is related to: i) reduction in LDL cholesterol; ii) improvement in endothelial function (in sub-study). 3) Treatment of ED with Simvastatin is cost effective ;Primary end point(s): Erectile dysfunction (ED) measured by the 5 item version of the International Index of Erectile Function (IIEF-5) This is a validated self-administered questionnaire requiring those completing it to have attempted vaginal sexual intercourse in the preceding four weeks. Each item scores 1 to 5 giving a total from 5 to 25. A score > 21 denotes no ED, 21-17 mild ED, 16-12 moderate ED and 7-5 severe ED. Those with scores < 22 are eligible unless receiving treatment for ED. | — |
Countries
United Kingdom
Outcome results
None listed