A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 395
- 主要终点
- Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
研究概览
简要总结
This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in patients with co-morbid factors associated with erectile dysfunction (also called impotence). The duration of erection endpoint will be assessed by patient utilized stopwatch timings during each attempt at sexual intercourse. Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug Administration for the treatment of erectile dysfunction. While there is no intent to assess the effect vardenafil has on blood lipids, the study will provide prospective data on men diagnosed with both ED and dyslipidemia.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- •Stable heterosexual relationship for more than 6 months
- •Between 18 and <65 years of age
- •Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) >/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated
- •InternationaI Index of Erectile Function - Erectile Function domain score of <25, denoting mild to severe ED at Visit 2
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 US Product Information
研究组 & 干预措施
Arm 1
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
干预措施: Placebo (Drug)
结局指标
主要结局
Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
时间窗: 12 weeks
次要结局
- Duration of erection leading to positive Sexual Encounter Profile Question 3(12 weeks)
- Safety and tolerability(12 weeks)
- Other patient diary based variables(12 weeks)