NCT00421083已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess Efficacy and Safety of Tadalafil (LY450190) in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
研究概览
简要总结
This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •males who developed erectile dysfunction as a result of spinal cord injury. Injury must have occurred 6 months before the start of the study.
- •at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance
- •no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. Also cannot use any other erectile dysfunction treatment during the study.
排除标准
- •Impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism
- •History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant.
- •History of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
- •Significant renal problems within 6 months before starting the study. Also, active liver disease including jaundice at beginning of study.
- •History of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.
结局指标
主要结局
Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
次要结局
- Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.
研究者
研究点 (1)
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