Oral Administration of L-Arginine in Patients With Erectile Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- International Index of Erectile Dysfunction
研究概览
简要总结
The purpose of the study is to determine whether the treatment with L-arginine leads to an improvement of erectile dysfunction in patients with erectile dysfunction.
详细描述
Erectile dysfunction (ED) is a common medical disorder often affecting the aging male. Nitric oxide (NO) is a physiological signal essential to penile erection. NO synthase (NOS) catalyzes the production of NO from L-arginine. ADMA, a competitive inhibitor of NO synthase increases with age and many disorders that reduce NO in the erectile tissue are commonly associated with ED. Although new pharmacological strategies have been identified for medical treatment of ED, patients often seek alternative therapies for cost or side effect reasons.
The aim of the present study is to determine the efficacy of orally administered L-arginine on ED not caused by established organic disease.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients age between 20 and 65 years, an ED for at least 6 months duration and written consent.
- •Each patient had to be informed about the study details in written and oral form before the beginning of the drug administration.
- •The hormonal status including dehydroepiandrosterone sulfate (DHEAS), Prolactin and Testosteron of each patient had to be within the normal range. -
排除标准
- •Patients with primary erectile dysfunction, congenital anomalies, Diabetes mellitus, severe hepatic-and renal insufficiency, severe cardiovascular diseases, cerebrovascular accidents, uncontrolled hypertension, endocrine diseases, psychiatric disorders, and evidence of dementia were excluded.
- •Patients were excluded if they had pelvic fractures or prostatectomy and if they had undergone reconstructive or prosthetic surgery on the penis.
- •Increased levels of serum potassium, known hypersensitivity to the study medication or any ingredient of the drug.
- •Administration of PDE-5-Inhibitors (sildenafil, tadalafil, vardenafil or apomorphine) within four weeks prior to the administration of l-arginine or placebo led to exclusion.
研究组 & 干预措施
L-arginine
干预措施: L-arginine (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
International Index of Erectile Dysfunction
时间窗: 16 weeks
次要结局
- L-arginine plasma-levels(16 weeks)