NCT00654680已完成3 期
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 418
- 主要终点
- International Index of Erectile Function-Erectile Function domain
研究概览
简要总结
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
- •Stable heterosexual relationship for at least 1 month.
排除标准
- •Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
- •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 US Product Information or Summary of Product Characteristics
研究组 & 干预措施
Arm 1
Experimental
干预措施: Vardenafil (Levitra, BAY38-9456) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (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
- Other diary based variables(12 weeks)
- Sexual Encounter Profile Question 2(12 weeks)
- Sexual Encounter Profile Question 3(12 weeks)
- Safety and tolerability(12 weeks)
研究者
相似试验
已完成
4 期
Assess Efficacy in Subjects With Traumatic Spinal Cord InjuryErectile DysfunctionSpinal Cord InjuryNCT00667966Bayer45
已完成
3 期
Study Evaluating the Efficacy, Safety, and Reliability of VardenafilErectile DysfunctionNCT00661297Bayer523
已完成
3 期
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile DysfunctionErectile DysfunctionNCT00658177Bayer463
已完成
3 期
Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile DysfunctionErectile DysfunctionNCT00657033Bayer229
已完成
2 期
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile DysfunctionErectile DysfunctionNCT00656188Bayer463