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:
320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 243 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Sep 2026, 49 months after the start.
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Hospital de Niños R. Gutierrez de Buenos Aires