NCT00151463已完成4 期
An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年1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
- 100
- 试验地点
- 9
- 主要终点
- Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
研究概览
简要总结
The Quality of Erection Questionnaire (QEQ) is a new questionnaire that was developed to assess erectile attributes in men with erectile dysfunction. The study objective is to validate the Quality of Erection Questionnaire (QEQ) through the evaluation of subject responses to the QEQ regarding the quality and hardness of erections at baseline compared to subject responses post 6 and 10 weeks dosing with Viagra (sildenafil citrate).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have documented clinical diagnosis of erectile dysfunction based on a screening SHI-M score of <21 and the subject fulfilling the NIH definition of erectile dysfunction
- •Subjects must be either PDE-5 inhibitor naive; i.e. have never used sildenafil, tadalafil or vardenafil, or have been previously treated with no more than six doses of a PDE-5 inhibitor (sildenafil, tadalafil, vardenafil) and must have taken their last dose no less than 4 weeks prior to the screening visit
排除标准
- •Subjects who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
结局指标
主要结局
Treatment response to the Quality of Erection Questionnaire (QEQ) after treatment with Viagra in men with erectile dysfunction
次要结局
- Change from baseline to week 6 of the QEQ total score
- Change from baseline to week 6 in the 5 IIEF domain scores
- Change from baseline in scores of QEQ individual question
研究者
研究点 (9)
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