Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity<30cm/s, diastolic velocity<5cm/s)
- •two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a HbA1c<7%)
- •stable course of disease without expected changes in medical treatment during the next 3 months
- •written informed consent
- •no statin-treatment so far
排除标准
- •known hypersensitivity or anaphylaxis against a statin
- •active liver disease or unclear increase of transaminases, cholestasis or myopathy
- •acute cardiovascular event (myocardial infarction, stroke, PTCA, vascular surgery) within 3 months before randomization
- •clinical signs of heart failure or reduced left ventricular function
- •current treatment with lipid lowering drugs
- •insulin dependent diabetes mellitus or orally treated diabetes mellitus with a HbA1c-value >6.9%
- •erectile dysfunction due to hormone disorders
- •known malignant tumor
- •known disposition to priapism
- •patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis
- •current treatment with anticoagulants
- •current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates
- •absence or inability of written informed consent
结局指标
主要结局
Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.
次要结局
- 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.