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

Hospital de Niños R. Gutierrez de Buenos Aires

Status and phase: Completed; Phase 3

Conditions: Sexual Precocity; Central Precocious Puberty

Treatments: Diagnostic Test: Gonadorelin acetate and Triptorelin acetate; Diagnostic Test: Triptorelin acetate and Gonadorelin acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01278290

HNinosBuenosAires-Triptorelin

Details and patient eligibility

About

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

Full description

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).

Enrollment: 46 patients

Sex: Female

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Triptorelin test AND LHRH test

Active Comparator group

Description:

Patients undergo two tests with a test interval of at least 15 days

Treatment:

Diagnostic Test: Triptorelin acetate and Gonadorelin acetate

LHRH test AND Triptorelin test

Active Comparator group

Description:

Patients undergo two test with a test interval of al least 15 days.

Treatment:

Diagnostic Test: Gonadorelin acetate and Triptorelin acetate