NCT00547495已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
研究概览
简要总结
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •3 months history of erectile dysfunction (ED)
- •Anticipate a monogamous relationship with a female sexual partner
- •Be able to make minimum required sexual intercourse attempts
- •Abstain from using any other ED treatment
排除标准
- •Other primary sexual disorders
- •History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
- •History of penile implant or clinically significant penile deformity.
- •Nitrate use
- •Certain heart problems
研究组 & 干预措施
1
Placebo Comparator
Placebo tablet
干预措施: placebo (Drug)
4
Active Comparator
20 mg tadalafil
干预措施: tadalafil (Drug)
3
Active Comparator
10 mg tadalafil
干预措施: tadalafil (Drug)
2
Active Comparator
5 mg tadalafil
干预措施: tadalafil (Drug)
结局指标
主要结局
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
时间窗: 12 weeks
次要结局
- Change from baseline to endpoint of various questions from the IIEF and SEP diary(12 weeks)
研究者
研究点 (1)
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