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Triptorelin for Early Diagnosis of Hypogonadotrophic Hypogonadism | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

Triptorelin for Early Diagnosis of Hypogonadotrophic Hypogonadism

Early Diagnosis of Hypogonadotrophic Hypogonadism by a Gonadotrophic-gonadal Stimulation Test with GnRH Agonist (Triptorelin)

NCT06691815•Hospital de Niños R. Gutierrez de Buenos Aires

View on ClinicalTrials.gov

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

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Female patients presenting with Tanner breast stage 1 or 2 at age ≥ 13 years or male patients with testicular volume \< 5 cc at age ≥ 13.5 years, or who have had pubertal changes but have arrested pubertal development for a period of one year. Female patients presenting with primary amenorrhea (absence of menarche at age 15) \> 4 years after the onset of puberty or secondary amenorrhea \> 6 months with no other apparent cause (having ruled out other hormonal disorders such as premature ovarian failure, hypothyroidism, hyperprolactinemia, non-classical congenital adrenal hyperplasia, and polycystic ovary syndrome) may also be included. Patients with or without olfactory disorders, and with or without a previous diagnosis of other pituitary deficiencies will be included. In the case of a history of CNS tumor pathology, inclusion in this study will be considered only if the patient is in remission from the oncological disease and if they have received CNS radiotherapy, at least one year has passed since the beginning of the treatment.
•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 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.

Locations (1)

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, Argentina

Key Dates

Start Date

August 1, 2022

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

November 15, 2024

Enrollment

ESTIMATED participants

Conditions

Pubertal DelayHypogonadism, HypogonadotropicConstitutional Delay in Growth and Puberty (CDGP)

Interventions

Triptorelin (GnRH agonists)

DIAGNOSTIC_TEST

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

NCT03490513

Hypogonadism, HypogonadotropicObesity

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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