NCT01106118已完成不适用
Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,289
- 主要终点
- The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)
研究概览
简要总结
The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.
- •Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.
- •No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.
- •Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.
排除标准
- •Do not follow the contraindications and warnings of the Summary of Product Characteristics.
研究组 & 干预措施
Group 1
干预措施: Vardenafil (Levitra, BAY38-9456) (Drug)
结局指标
主要结局
The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)
时间窗: After approx 12 weeks
次要结局
- Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks(After approx. 12 weeks)
- Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks(After approx. 12 weeks)
- Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks(After approx. 12 weeks)
- Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale(After approx. 12 weeks)
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