NCT00256399已完成不适用
A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluate the medication on erection maintenance
研究概览
简要总结
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.
详细描述
The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 45-75 years of age
- •Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
- •Men with steady partner and who agree to attempt sex once a week.
排除标准
- •Prostate cancer
- •Prostatitis
- •Penile disease
- •Cardiac co-morbidity
- •Pre-existing co-morbid conditions
- •History of sensitivity to the drug or similar drugs
- •Enrollment in another clinical trial
- •Impaired hepatic function
- •Impaired renal function
- •Mental conditions rendering subject unable to understand the study
- •Subjects not likely to comply with protocol
结局指标
主要结局
Evaluate the medication on erection maintenance
次要结局
- Assess effect of Uroxatral on BPH and sexual function using questionnaires
研究者
研究点 (2)
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