NCT00663130已完成4 期
A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction
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
- Bayer
- 入组人数
- 759
- 主要终点
- Sexual Encounter Profile Question 3 (SEP-3)
研究概览
简要总结
Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED
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
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 64 years
- •Heterosexual males
- •Erectile dysfunction for more than 6 months
排除标准
- •Penile anatomical abnormalities
- •Spinal cord injury
- •History of surgical prostatectomy
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Active Comparator
干预措施: Tadalafil (Drug)
结局指标
主要结局
Sexual Encounter Profile Question 3 (SEP-3)
时间窗: 4 weeks
次要结局
- General Safety(4 weeks)
- Sexual Encounter Profile Question 2 (SEP-2)(4 weeks)
- Global Confidence Question (GCQ)(4 weeks)
- International Index of Erectile Function(4 weeks)
- Erection Quality Scale (EQS)(4 weeks)
研究者
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