NCT00668096已完成4 期
A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.
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
- 260
- 主要终点
- Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
研究概览
简要总结
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.
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 with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
- •Heterosexual relationship for more than 6 months
- •Partner willing to complete the TSS
排除标准
- •Primary hypoactive sexual desire
- •History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- •Nitrate use
- •Other exclusion criteria apply according to the Summary of Product Characteristics
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
结局指标
主要结局
Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
时间窗: 16 weeks
次要结局
- Treatment Satisfaction Scale(16 weeks)
- Other patient diary based variables(16 weeks)
- Safety and tolerability(16 weeks)
- International Index of Erectile Function(16 weeks)
研究者
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