NCT00654082已完成4 期
A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2002年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections
研究概览
简要总结
To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients were men with spinal cord injury and erectile dysfunction
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: sildenafil (Drug)
Arm 2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections
时间窗: Weeks 6 and 14
次要结局
- Responses to the Global Efficacy Assessment (GEA) Question(Weeks 0, 6, 8, and 14)
- Responses to questions on the Quality of Life (QoL) Questionnaire(Weeks 0, 6, 8, and 14)
- Responses to the International Index of Erectile Function (IIEF)(Weeks 0, 6, 8, and 14)
- Intercourse success rate derived from patient event log(Weeks 0, 6, 8, and 14)
- Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions(Weeks 0, 6, 8, and 14)
研究者
研究点 (1)
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