Can simvastatin improve erectile function and health-related quality of life in men aged over 40 years with erectile dysfunction? : Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971]

OBJECTIVE To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction. PATIENTS AND METHODS The study is a randomized, double-blind, placebo-controlled trial to test the hypotheses that statins improve endothelial function and reduce cholesterol and may improve erectile function in men with untreated erectile dysfunction (ED). Study subjects are men ≥40 years who are not receiving lipid-lowering or anti-hypertensive medication and have no other cardiovascular disease (CVD) risk factors. Eligible men with untreated ED are randomized to double-blind treatment with 40 mg simvastatin or placebo once daily for 6 months. Data are collected at baseline, mid-trial and at the final follow-up visit at 30 weeks. The main outcome is erectile function measured by the five-item version of the International Index of Erectile Function. Secondary outcomes include sexual-health-related quality of life and endothelial function. RESULTS Ten general practices have been recruited in the east of England. We have randomized 173 men for a power of 90% to assess the main outcome. To date there have been no serious unexpected adverse events. Study findings will be available in September 2011. CONCLUSIONS If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD.