Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

December 22, 2021 updated by: Zhaoyun Zhang, Huashan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of luteinizing hormone, follicle stimulating hormone and testosterone
Time Frame: 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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2021-674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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