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临床试验/NCT02111434
NCT02111434已完成4 期

Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism

Gulhane School of Medicine1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
time to change of visceral adiposity index with testosteron replacement

研究概览

简要总结

The study is designed to answer the following questions:

  1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism?
  2. What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

详细描述

This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Congenital hypogonadism
  • Treatment Naive

排除标准

  • Previous history of androgen replacement
  • Hypertension
  • Diabetes mellitus

研究组 & 干预措施

testosterone

Experimental

testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months

干预措施: Testosterone (Drug)

结局指标

主要结局

time to change of visceral adiposity index with testosteron replacement

时间窗: baseline and 6 months

time to change of TG/HDL cholesterol ratio with testosteron replacement

时间窗: baseline and 6 months

次要结局

未报告次要终点

研究者

发起方
Gulhane School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

cem haymana

MD

Gulhane School of Medicine

研究点 (1)

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