Triptorelin for Early Diagnosis of Hypogonadotrophic Hypogonadism

NCT06691815 | Enrolling By Invitation DMC

• 2 other identifiers: Hospital de Niños R. GutierrezCEI 22.23
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Triptorelin test (subcutanous)
• LHRH infusion test

Conditions

Pubertal Delay; Hypogonadism, Hypogonadotropic; Constitutional Delay in Growth and Puberty (CDGP)

Keywords

Hypogonadism, hypogonadotropic; Constitutional Delay in Growth and Puberty; Pubertal Delay; GnRH agonist test; Gondotropins; gonadal steroids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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 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)

Interventions

Triptorelin (GnRH agonists) DIAGNOSTIC_TEST

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

Unique arm

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if, due to previous history or relevant clinical history or initial laboratory study, another cause is determined to explain their pubertal disorder: primary hypogonadism (hypergonadotrophic or premature ovarian failure), low weight with BMI \< 18, untreated hypothyroidism, hyperprolactinemia, hyperandrogenism, Cushing\'s syndrome, current prolonged corticosteroid treatment, active systemic disease, CRF or competitive training \> 10 hours/week, diabetes mellitus without adequate control or celiac disease without compliance with a gluten-free diet.
• 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.

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, 1425, Argentina

Location

MeSH Terms

Conditions

Puberty, Delayed; Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The order in which the tests will be performed will be randomized at the time the patients are included in the study. 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 (Lu

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 15, 2024
• Study Start: August 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-09

Locations

AR (1)