NCT00663598已完成4 期
REALISE Levitra® - Real Life Safety and Efficacy of Levitra
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
- 30,825
- 主要终点
- Improvement of Erectile Disfunction
研究概览
简要总结
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)
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
- •Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment
排除标准
- •Exclusion according to US PI
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
Improvement of Erectile Disfunction
时间窗: 8 weeks
Second successful intercourse
时间窗: 8 weeks
Onset of Drug Effect
时间窗: 8 weeks
次要结局
- General Safety Parameters(8 weeks)
研究者
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