NCT01148433已完成不适用
Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 22
- 主要终点
- Serum Testosterone Level
研究概览
简要总结
The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •therapeutic need according to SPC
- •written informed consent
排除标准
- •contraindications according to SPC
结局指标
主要结局
Serum Testosterone Level
时间窗: 6 months
Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)
次要结局
- Quality of Life - (determined by the MFI questionnaire)(6 months)
- Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)(6 months)
- Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)(6 months)
- Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)(6 months)
- Laboratory Parameters: PSA and Haematocrit levels(6 months)
研究者
研究点 (22)
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