NCT00665340已完成4 期
A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo 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
- 219
- 主要终点
- Erection Quality Scale
研究概览
简要总结
This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 who have had ED for at least six months- Heterosexual relationship.- Males 18 and older.
排除标准
- •Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information
研究组 & 干预措施
Arm 1
Placebo Comparator
干预措施: Placebo (Drug)
Arm 2
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
结局指标
主要结局
Erection Quality Scale
时间窗: Week 8
次要结局
- Erection Quality Scale(Week 4 and 8)
- International Index of Erectile Function- Erectile Function domain score(Week 4 and 8)
- Patient Diary Questions(Weeks 4, 8 Week 8)
- Penetration (SEP2) and Maintenance (SEP3) reliability(Week 8-LOCF)
- Per-subject success rates based on Sexual Encounter Profile, Question 2(Week 4, 8 Week 8)
- Safety and tolerability(Week 8)
- Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)(Week 8-LOCF)
- Global Assessment Question (GAQ)(Weeks 4, 8 of treatment and Week 8)
研究者
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