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

Central Precocious Puberty Clinical Trial

Official title:
Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.

Clinical Trial Summary

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

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01278290
Study type Interventional
Source Hospital de Niños R. Gutierrez de Buenos Aires
Contact
Status Completed
Phase Phase 3
Start date December 2009
Completion date June 2011
View Details
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