NCT00382135已完成4 期
An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change in sperm production measured at baseline and after 9 months of treatment.
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects or men with mild erectile dysfunction
- •At least 45 years of age
- •With specified semen characteristics.
排除标准
- •Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- •A history of certain endocrine or hormonal abnormalities
- •A history of significant testicular/genital abnormalities
- •Any significant reproductive abnormality identified at the start of the study.
研究组 & 干预措施
1
Placebo Comparator
placebo tablet
干预措施: placebo (Drug)
2
Active Comparator
20 mg tadalafil tablet
干预措施: tadalafil (Drug)
结局指标
主要结局
Change in sperm production measured at baseline and after 9 months of treatment.
时间窗: 40 weeks
次要结局
- Changes in other semen characteristics and reproductive hormones.(40 weeks)
研究者
研究点 (1)
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