NCT01278290

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires · Academic / Other
• Sex: Female
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Central Precocious Puberty
• Sexual Precocity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Triptorelin acetate and Gonadorelin acetate	Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.
DIAGNOSTIC_TEST	Gonadorelin acetate and Triptorelin acetate	Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-01-17
• Last updated: 2021-01-06

Locations

1 site across 1 country: Argentina