NCT00542165已完成4 期
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- IIEF and GEQ (Global Efficacy Question)
研究概览
简要总结
To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients suffering from LUTS lasting 6months and over
- •male patients aged 50 years old and over who has a continuous active partner
排除标准
- •Primary hypogonadism and neuropathy patients
- •History of prostate surgery
- •Patients with prostate cancer
- •History of organ surgery or organ damage in pelvis
- •History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months
- •Patients with haematuria caused by other reasons except BPH
- •Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents
- •History of a malignant tumor within last 5 years
- •Patients who are currently controlled with other medication for erectile dysfunction
- •Patients who have been administered with androgen or antiandrogen
- •Patients who is treated for psychiatric disorder or depression
- •Combination with other alpha1-blockers
- •Patients previously not improved by an alpha1-blocker treatment
- •Known hypersensitivity to the alfuzosin
- •History of postural hypotension or syncope
- •Hepatic insufficiency
- •Unstable angina pectoris
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
IIEF and GEQ (Global Efficacy Question)
时间窗: at intermediate visit (M1) and at end-point visit(M3)
次要结局
- blood pressure and heart rate measure in sitting position(at each visit)
- IPSS and Quality of Life Score(at intermediate visit (M1) and at end-point visit(M3))
- Maximum flow rate and post voiding residual urine(at end-point visit(M3))
- Spontaneous reported adverse events(During all the study period)
研究者
研究点 (1)
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