Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- testicular volume
研究概览
简要总结
Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.
详细描述
Observe safety and efficacy of human menopausal gonadotropin and human chorionic gonadotropin treating congenital hypogonadotropic hypogonadism in teenagers; which as clinic recommendation, may provide clinical basis for establishing standard treatment guideline in the future. Establish technological process and follow-up precept for human menopausal gonadotropin and human chorionic gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers. And find safety and effective dose for teenagers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 138 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any ascertain reason contributes to the non puberty development (Chromosome abnormal, trauma, surgeries) or any ascertain disease such as Prader-Willi syndrome or hypergonadotropic hypogonadism
- •Systemic diseases (such as chronic kidney failure, Mediterranean anemia, poor controlled diabetes)
- •Protein-energy malnutrition
- •Eating disorder (such as anorexia nervosa, binge eating)
- •Any brain diseases history: tumors in brain or pituitary or after their surgeries
研究组 & 干预措施
Human Menopausal Gonadotropin
Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)
干预措施: Human Menopausal Gonadotropin (Drug)
Human Menopausal Gonadotropin
Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)
干预措施: Human Chorionic Gonadotropin (Drug)
Human Chorionic Gonadotropin
Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation
干预措施: Human Chorionic Gonadotropin (Drug)
结局指标
主要结局
testicular volume
时间窗: Change from Baseline testicular volume at 3 months after treatment
次要结局
- The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys)(Testosterone changes from 3 months onwards after treatment compared to pretreatment)
研究者
Chunxiu Gong
Professor
Beijing Children's Hospital