Triptorelin for Early Diagnosis of Hypogonadotrophic Hypogonadism

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypogonadism, Hypogonadotropic; Constitutional Delay in Growth and Puberty (CDGP); Pubertal Delay
• Intervention / Treatment: Diagnostic test: Triptorelin (GnRH agonists)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Hospital de Niños Dr. Ricardo Gutierrez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Unique arm; All patients will be randomized only to the order of the test to be performed. All patients included will be performed two tes; 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.; 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); 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.; 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); Other Names: Triptorelin 0.1 mg subcutaneos test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Hypogonadism, hypogonadotropic; Constitutional Delay in Growth and Puberty; Pubertal Delay; GnRH agonist test; Gondotropins; gonadal steroids
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Puberty, Delayed; Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Luteolytic Agents; Contraceptive Agents, Female; Contraceptive Agents; Triptorelin Pamoate
• Other Study ID Numbers: Hospital de Niños R. Gutierrez; CEI 22.23 (Other Identifier: Ethics Committee of the Hospital de Niños Dr. Ricardo Gutiérrez)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No