Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

Fudan University

Status: Unknown

Conditions: Hypogonadotropic Hypogonadism

Treatments: Drug: Gonadorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT05184374

KY2021-674

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

subcutaneous injection of gonadorelin is facilitated by GnRH pump

Experimental group

Description:

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

Treatment:

Drug: Gonadorelin