Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction|
- Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.
- Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.
- Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||December 2007|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382161
|University Hospital of the Saarland|
|Homburg, Saarland, Germany, 66421|
|Principal Investigator:||Magnus Baumhäkel, MD||University Hospital of the Saarland|
|Principal Investigator:||Michael Böhm, MD||University Hospital of the Saarland|
|Principal Investigator:||Martin Gerber, MD||University Hospital of the Saarland|
|Principal Investigator:||Michael Stöckle, MD||University Hospital of the Saarland|