临床试验/NCT00941343

NCT00941343已完成不适用

Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

Sanofi1 个研究点分布在 1 个国家目标入组 362 人开始时间: 2006年9月最近更新: 2010年3月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Sanofi
入组人数: 362
试验地点: 1
主要终点: Male Sexual Health Questionnaire Ejaculation score (MSHQ)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objective:

To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders
To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions
To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)
To assess the onset of action of XATRAL 10mg OD
To assess the peak urinary flow rate
To assess the safety and the tolerability of XATRAL 10mg OD

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: 40 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

1

Experimental

XATRAL 10mg OD

干预措施: Alfuzosin (XATRAL® - SL770499) (Drug)

结局指标

主要结局

Male Sexual Health Questionnaire Ejaculation score (MSHQ)

时间窗: At week 24

次要结局

MSHQ Ejaculation score(At week 14, 12 and 24)
International Prostate Symptom Score (I-PSS) including quality of life index(At week 1, 4, 12 and 24)
Systolic and diastolic blood pressure(At week 1, 4, 12 and 24)
Heart rate(At week 1, 4, 12 and 24)
Prostate Specific Antigen(At week 24)

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (1)

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