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临床试验/NCT00847314
NCT00847314已完成不适用

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

Bayer0 个研究点目标入组 30 人开始时间: 2007年6月最近更新:
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
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

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

研究者

发起方
Bayer
申办方类型
Industry

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