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临床试验/NCT00700024
NCT00700024Unknown4 期

The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Lean body mass

研究概览

简要总结

The purpose of this study is to determine the effect of training and testim on Hypogonadism.

详细描述

The effect of testim and training in hypogonadal men.

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
65 Years 至 78 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male 65-78
  • Bioavailable testosterone < 7.3 nmol/L
  • Waist > 94 cm

排除标准

  • Haematocrit > 0.50
  • Known c. prostate or PSA > 3 Myg/L
  • Known malignant disease
  • Alcohol or drug abuse
  • BMI > 40 kg/m2
  • Use of 5 alpha reductance inhibitors
  • Plan to father children

研究组 & 干预措施

1

Active Comparator

testim

干预措施: Testim (Drug)

2

Experimental

placebo

干预措施: placebo (Drug)

3

Experimental

training

干预措施: Strength training (Behavioral)

结局指标

主要结局

Lean body mass

时间窗: january 2008-january 2010

次要结局

  • Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone(january 2008-january 2010)

研究者

申办方类型
Other

研究点 (1)

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