Erectile dysfunction caused by vascular impairment Urological and Genital Diseases
Conditions
Interventions
Simvastatin one 40 mg tablet orally daily at bedtime for 6 months or matched placebo one tablet orally daily at bedtime.
Sponsors
University of Hertfordshire (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 40 years and over 2. In a stable heterosexual relationship for at least 6 months 3. No clinically overt cardiovascular risk factors other than raised cholesterol 4. Not currently on lipid or erectile dysfunction therapy 5. Untreated erectile dysfunction defined as score <22 on the International Index of Erectile Function 5 item questionnaire
Exclusion criteria
Exclusion criteria: 1. Diabetes, past history of myocardial infarction, hospitalised angina or stroke 2. Hypertension - systolic blood pressure >=170 mmHg, diastolic >=100 mmHg 3. Ratio total:high-density lipoproteins (HDL) cholesterol >=6 4. Total cardiovascular risk >= 20% over next 10 years 5. Current lipid lowering therapy 6. Erectile dysfunction therapy in the last 3 months 7. Hypogonadism 8. Chronic liver disease or abnormal liver function 9. Severe renal disease or evidence of impaired renal function 10. Inflammatory muscle disease or evidence of muscle problems 11. Concomitant administration of contra-indicated drugs: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, telithromycin and nefazodone 12. Concomitant administration of other drugs associated with increased risk of myopathy/rhabdomyolysis: ciclosporin, danazol and fusidic acid 13. Galactose intolerance, Lapp lactase deficiency or glocose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erectile dysfunction measured by the 5 item version of the International Index of Erectile Function (IIEF-5) All primary and secondary outcomes will be assessed at baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Erectile function as measured by the Sexual Encounter Profile diaries 2. Quality of life (QOL), assessed by the Male Erectile Dysfunction specific questionnaire (MED-QOL) and euroqol EQ-5D 3. Total LDL, HDL cholesterol in fasting blood samples 4. Use of health services and cost of statins 5. Endothelial function measured by pulse wave analysis in a 10% sub-sample All primary and secondary outcomes will be assessed at baseline and 6 months. | — |
Countries
United Kingdom
Outcome results
None listed