NCT00786253已完成2 期
A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 236
- 主要终点
- Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
研究概览
简要总结
Compare once daily vs on demand treatment in men with erectile dysfunction.
Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:
A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks
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
- •Males 18-64 years of age
- •Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
- •History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
- •Stable, heterosexual relationship for more than six months
排除标准
- •Primary hypoactive sexual desire
- •History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- •Nitrate therapy.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
结局指标
主要结局
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
时间窗: 12- 24 weeks
次要结局
- SEP 3(12- 24 weeks)
- SEP 2(12- 24 weeks)
研究者
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