Impotence Clinical Trial
Official title:
Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
Physiology of erection is mainly dependent on endothelial NO-production with consecutive
activation of guanylate-cyclase. Pleiotropic effects of statins are well known regarding the
increase of endothelial function. Thus, activation of endothelial NO-synthase could raise
the activation of guanylate-cyclase with a consecutive relaxation of smooth muscle cells in
the penile arteries and the corpus cavernosum leading to an improvement of erectile
function. Therefore, statins are supposed to be effective in the treatment of erectile
dysfunction, especially in patients with cardiovascular risk-factors with underlying
endothelial dysfunction.
The effect of fluvastatin on penile blood-flow and erectile function in patients with
arteriogenic erectile dysfunction and cardiovascular risk factors will be determined in a
cross-over design. Patients were either treated with fluvastatin-sodium 80mg or placebo for
8 weeks. After a wash-out of 4 weeks, treatment will be switched (placebo /
fluvastatin-sodium). Penile blood flow measurement and assessment of erectile function with
the IIEF-5-score and the KEED-score will be performed at baseline, after 8 weeks of
treatment, after 4 weeks wash-out and after cross-over treatment (8 weeks).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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