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| ID | Type | Description | Link |
|---|---|---|---|
| CEI 22.23 | Other Identifier | Ethics Committee of the Hospital de Niños Dr. Ricardo Gutiérrez |
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The goal of this clinical trial is to learn if Triptorelin test works to early diagnose hypogonadotrophic hypogonadism in adolescents. The main questions it aims to answer are:
• Does gonadotropin and gonadal steroids responses to Triptorelin test be useful to diagnose early hypogonadotrophic hypogonadism? Researchers will compare gonadotrophins and gonadal steroids in response to Triptorelin subucutaneos test with clasiccal GnRH infusion to diagnose hypogonadotrophic hypogonadism.
Participants will performed two test:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unique arm | Experimental | All patients will be randomized only to the order of the test to be performed. All patients included will be performed two tes
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin (GnRH agonists) | Diagnostic Test |
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| Measure | Description | Time Frame |
|---|---|---|
| LH-3 hs, FSH-3 hs, Estradiol-24 hs, Testosteron-24 hs | LH, FSH, Estradiol or Testosterone meassurement in samples 3 hs o 24 hs after triptorelin subcutaneous administration | -To finish spontanous puberty or to get the definitive diagnosis of hypogonadotrophic hypogonadism |
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Inclusion Criteria:
If patients have started HRT, they may be included as long as they stop taking it for two half-lives of the compound used, therefore a 2-month free period is necessary for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for testosterone undecanoate injections.
Exclusion Criteria:
Patients who do not provide an updated medical history, who do not provide consent, or whose parents or guardians do not provide assent will be excluded. Patients who are receiving hormone replacement therapy and refuse to stop during the 2-month period for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for quarterly depot injections of testosterone undecanoate will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Niños Dr. Ricardo Gutiérrez | Buenos Aires | 1425 | Argentina |
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| ID | Term |
|---|---|
| D011628 | Puberty, Delayed |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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The order in which the tests will be performed will be randomized at the time the patients are included in the study.
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