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临床试验/NCT05184374
NCT05184374Unknown不适用

Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
level of luteinizing hormone, follicle stimulating hormone and testosterone

研究概览

简要总结

The Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Gonadotropin-releasing hormone(GnRH) stimulation test is used to evaluate the function of pituitary-gonadal axis. GnRH can be used to diagnose and treat fertility disorders and other endocrine disorders caused by HH. After a single injection of GnRH, the patients with poor response of luteinizing hormone and follicle stimulating hormone need to take extended provocation test, which is conducive to the formulation of the following treatment. GnRH pump can pulse subcutaneous injection of gonadorelin, which can be used as the extended provocation test.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • patients with HH after surgery of the saddle area
  • sufficient therapy of the hypothalamic-pituitary-adrenal(HPA) and hypothalamic-pituitary-thyroid(HPT) axis

排除标准

  • contradictions to gonadorelin
  • androgen-dependent prostate cancer
  • on the therapy of human chorionic gonadotropin(HCG) or testosterone

研究组 & 干预措施

subcutaneous injection of gonadorelin is facilitated by GnRH pump

Experimental

After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month.

干预措施: Gonadorelin (Drug)

结局指标

主要结局

level of luteinizing hormone, follicle stimulating hormone and testosterone

时间窗: 1 month

after the GnRH pump of gonadorelin, the level of luteinizing hormone, follicle stimulating hormone and testosterone will be measured at 24h, 1, 2, 3 and 4 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoyun Zhang

vice director of endocrine department

Huashan Hospital

研究点 (1)

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