Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

Sponsor

Huashan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05184374

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadotropic Hypogonadism	Drug: Gonadorelin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: subcutaneous injection of gonadorelin is facilitated by GnRH pump After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month.	Drug: Gonadorelin GnRH pump pulse subcutaneous injection of gonadorelin in a month

Arm

Intervention/Treatment

Experimental: subcutaneous injection of gonadorelin is facilitated by GnRH pump

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

Drug: Gonadorelin

GnRH pump pulse subcutaneous injection of gonadorelin in a month

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhaoyun Zhang, vice director of endocrine department, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT05184374

Other Study ID Numbers:

KY2021-674

First Posted:

Jan 11, 2022

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypogonadism

Prolactin Release-Inhibiting Factors

Study Results

No Results Posted as of Jan 11, 2022