Back to resultsEfficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
Primary Purpose
Hypogonadotropic Hypogonadism
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gonadorelin
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypogonadotropic Hypogonadism
Eligibility Criteria
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
Sites / Locations
- Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subcutaneous injection of gonadorelin is facilitated by GnRH pump
Arm Description
After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05184374
Brief Title
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
Official Title
Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous injection of gonadorelin is facilitated by GnRH pump
Arm Type
Experimental
Arm Description
After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month.
Intervention Type
Drug
Intervention Name(s)
Gonadorelin
Intervention Description
GnRH pump pulse subcutaneous injection of gonadorelin in a month
Primary Outcome Measure Information:
Title
level of luteinizing hormone, follicle stimulating hormone and testosterone
Description
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
Time Frame
1 month
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
the changes of LH, FSH are complicated during the menstrual cycle, so female was excluded.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuiyun Wu
Phone
+86(21)52888045
Email
mhe2004@263.net
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuiyun Wu
Phone
+86(21)52888045
Email
mhe2004@263.net
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH
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