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临床试验/NCT00140998
NCT00140998已完成3 期

Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery

Nemours Children's Clinic2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2001年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Rates of whole body protein kinetics

研究概览

简要总结

The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.

详细描述

Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study population. The study requires 3 overnight admissions to an in-patient Clinical Research Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA scan is used to measure bone mineral density and body composition. Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects continue to be on growth hormone throughout the study procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment.

排除标准

  • Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use.

结局指标

主要结局

Rates of whole body protein kinetics

Rates of whole body lipolysis

Body Composition

次要结局

  • Changes in Plasma Lipids
  • Changes in IGF-I concentrations

研究者

申办方类型
Other

研究点 (2)

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