Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
研究概览
简要总结
The study is designed to answer the following questions:
- What is the effect of testosteron replacement treatment on the endothelial dysfunction.
2/ What is the effect of testosteron replacement on the bone mineral metabolism.
详细描述
this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
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
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
the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.
时间窗: 6 months
Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA).
the effect of testosteron replacement treatment on the asymmetric dimethylarginine.
时间窗: 6 months
Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany)
the effect of testosteron replacement treatment on the vitamin D levels.
时间窗: 6 months.
Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system.
次要结局
未报告次要终点
研究者
cem haymana
MD
Gulhane School of Medicine