NCT00681772已完成4 期
Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males 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
- 333
- 主要终点
- International Index of Erectile Function - Erectile Function Domain
研究概览
简要总结
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men >/= 18 years of age,
- •ED 6 months or longer
- •Stable sexual relationship for > 6 month.
排除标准
- •Primary hypoactive sexual desire
- •History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- •Nitrate therapy
- •Other exclusion criteria apply according to the Summary of Product Characteristics
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
结局指标
主要结局
International Index of Erectile Function - Erectile Function Domain
时间窗: 12 weeks
次要结局
- Sexual Encounter Profile Question 2 and 3(12 weeks)
- Global Assessment Question(12 weeks)
- Other diary based variables(12 weeks)
- Safety and tolerability(12 weeks)
研究者
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