An interventional study of Triptorelin (GnRH agonists) in Pubertal Delay, Hypogonadism, Hypogonadotropic and Constitutional Delay in Growth and Puberty (CDGP), sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Enrolling by invitation at 1 site in Argentina. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Not applicable, Interventional, and Diagnostic
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:
Participants will performed two test:
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.
All patients will be randomized only to the order of the test to be performed. All patients included will be performed two tes 1. Triptorelin test. A baseline blood sample will be taken to determine LH, FSH, Estradiol/Testosterone. Then, Triptorelin Acetate 100 ug/m² of body surface area will be administered subcutaneously, maximum dose 0.1 mg (Decapeptyl Daily prefilled syringe of 0.1 mg) Three hours later, a new sample will be taken to determine LH and FSH. The patient may return home and lead a normal life. An appointment will be made the following day to perform the last sample of this test 24 hours after the subcutaneous administration of Triptorelin to the meassurement of LH, FSH, Estradiol/Testosterone, and Inhibin B. 2. GnRH Infusion: LH and FSH in baseline blood samples, 15, 30, 45, 60 and 120 minutes after slow infusion of GnRH. GnRH 0.83 μg/min during the 120 minutes that the study lasts (Luteoliberin 100 μg)
Diagnostic Test: Triptorelin (GnRH agonists)
1. Triptorelin test. A baseline blood sample will be taken to determine LH, FSH, Estradiol/Testosterone, AMH, and Inhibin B. Then, Triptorelin Acetate 100 ug/m² of body surface area will be administered subcutaneously, maximum dose 0.1 mg (Decapeptyl Daily prefilled syringe of 0.1 mg for subcutaneous administration. Three hours later, a new sample will be taken to determine LH and FSH. The patient may return home and lead a normal life. An appointment will be made the following day to perform the last sample of this test 24 hours after the subcutaneous administration of Triptorelin Acetate, with the determination of LH, FSH, Estradiol/Testosterone, and Inhibin B. 2. GnRH Infusion: This consists of determining LH and FSH in baseline blood samples, 15, 30, 45, 60 and 120 minutes after slow infusion of GnRH. GnRH 0.83 μg/min during the 120 minutes that the study lasts (Luteoliberin 100 μg)
Also known as: Triptorelin 0.1 mg subcutaneos test
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
Time frame: -To finish spontanous puberty or to get the definitive diagnosis of hypogonadotrophic hypogonadism
Plan to share: Undecided
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Hospital de Niños R. Gutierrez de Buenos Aires