NCT01230541已完成1 期
Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Sperm Concentration Reduction greater than or equal to 50% at Week 26
研究概览
简要总结
Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.
详细描述
Safety Study in male subjects with no or mild ED (erectile dysfunction)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No or mild ED (erectile dysfunction) willing & able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 & 26
- •BMI (body mass index) between 19 and 31 kilogram/meter squared
排除标准
- •New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
- •Nitrate medications for angina pectoris
- •Used of anti-arrhythmic drug treatment or device
- •Congestive heart failure
- •Uncontrolled diabetes
- •Stroke or transient ischemic attack (TIA) within last 6 months
- •Bleeding disorder or history of GI bleeding within last 12 months
- •Cancer chemotherapy
- •History of alcohol or drug abuse
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Udenafil
Active Comparator
Udenafil daily tablet
干预措施: Udenafil (Drug)
结局指标
主要结局
Sperm Concentration Reduction greater than or equal to 50% at Week 26
时间窗: 26 weeks
Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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