Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 主要终点
- Waist Circumference
研究概览
简要总结
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.
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
- 35 Years 至 64 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients > 35yrs
- •Waist Circumference > 102cm
- •Clinically and biochemically confirmed hypogonadism (testosterone group)
- •Willingness to attempt weight optimization
排除标准
- •Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours
- •hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
研究组 & 干预措施
Group 1
干预措施: Testosterone Undeconate (Nebido-R, BAY86-5037) (Drug)
结局指标
主要结局
Waist Circumference
时间窗: At each visit
次要结局
未报告次要终点
