NCT00143221已完成4 期
A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 350 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 主要终点
- Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
研究概览
简要总结
The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of erectile dysfunction (ED)
- •lower urinary tract symptoms (LUTS)
排除标准
- •previous prostate surgery or invasive intervention for BPH
- •active urinary tract disease
结局指标
主要结局
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
次要结局
- Effect on: IPSS Effect on IPSS QoL Orgasmic Function
- Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
- Event Log Variables
研究者
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