Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

Not Applicable

• Conditions: Hypogonadotropic Hypogonadism
• Interventions: Drug: Gonadorelin

• Registration Number: NCT05184374
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Last Update Submitted: 2021-12-22
• Study Start: 2022-01-01
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subcutaneous injection of gonadorelin is facilitated by GnRH pump	Gonadorelin	After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month.

Primary Outcome Measures

Name	Time	Method
level of luteinizing hormone, follicle stimulating hormone and testosterone	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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China