Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
This trial is active, not recruiting.
|Conditions||central precocious puberty, sexual precocity|
|Treatments||triptorelin acetate and gonadorelin acetate, gonadorelin acetate and triptorelin acetate|
|Sponsor||Hospital de Niños R. Gutierrez de Buenos Aires|
|Start date||July 2010|
|End date||April 2011|
|Trial size||40 participants|
|Trial identifier||NCT01278290, HNinosBuenosAires-Triptorelin|
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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 3 hs
time frame: 24 hs
time frame: 3 hs
Female participants from 3 years up to 8 years old.
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.
|Official title||Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.|
|Principal investigator||Analía V Freire, MD|
|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).|
Call for more information