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NCT05184374 Clinical Trial

Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

Hypogonadotropic Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05184374
Other study ID # KY2021-674
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2022

Study information
Verified date December 2021
Source Huashan Hospital
Contact Cuiyun Wu
Phone +86(21)52888045
Email mhe2004@263.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Gonadorelin
GnRH pump pulse subcutaneous injection of gonadorelin in a month

Locations
Country Name City State
China Huashan Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary level of luteinizing hormone, follicle stimulating hormone and testosterone 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 1 month
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