Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls

Hospital de Niños R. Gutierrez de Buenos Aires46 enrolled

Overview

The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard. Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment. Study population are girls with suspicious clinical features of precocious puberty

GnRH stimulation is the gold standard to distinguish between isolated premature thelarche (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries. To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP compared to the GnRH test, a validation study was performed. Girls who presented thelarche with accelerated growth and/or advanced bone age were included. All girls underwent the two tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold standard test).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Central Precocious Puberty Sexual Precocity

Interventions

Triptorelin acetate and Gonadorelin acetateDIAGNOSTIC_TEST

Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.

Gonadorelin acetate and Triptorelin acetateDIAGNOSTIC_TEST

Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Eligibility

Sex: FEMALEMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * premature thelarche and/or * accelerated growth velocity (above 90 percentile) * advanced bone age at least 1.5 year in relation to chronological age. Exclusion Criteria: * contact with sources of exogenous estrogens in the last four months previous to evaluation, * suspicion of peripheral precocious puberty, * previous central nervous system illness or suspicion of organic central precocious puberty.

Locations (1)

Hospital de Niños Ricardo Gutierrez, División de Endocrinología

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Time frame: 3 hs

Estradiol

Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Time frame: 24 hs

Secondary Outcomes

FSH

Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Time frame: 3 hs

Data from ClinicalTrials.gov

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