NCT00245596已完成4 期
An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of 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 120 人开始时间: 2005年10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
- 120
- 试验地点
- 9
- 主要终点
- Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
研究概览
简要总结
The purpose of the study is to assess the sensibility of the ISL questionnaire.
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
- •ED patient must:
- •Be male, 18 years of age with no upper age limit;
- •Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score
- •Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
- •Have a stable female partner for at least 6 months prior to screening.
排除标准
- •Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil
- •Be 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 responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
次要结局
- The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem
研究者
研究点 (9)
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