Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

NCT05184374 | Unknown

• 1 other identifier: KY2021-674
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: Gonadorelin

Interventions

Gonadorelin DRUG

GnRH pump pulse subcutaneous injection of gonadorelin in a month

subcutaneous injection of gonadorelin is facilitated by GnRH pump

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: the changes of LH, FSH are complicated during the menstrual cycle, so female was excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Cuiyun Wu

CONTACT

+86(21)52888045; mhe2004@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of endocrine department

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

CN (1)