Overview

This trial is active, not recruiting.

Conditions central precocious puberty, sexual precocity
Treatments triptorelin acetate and gonadorelin acetate, gonadorelin acetate and triptorelin acetate
Phase phase 4
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

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Patients undergo two tests with a test interval of at least 15 days
triptorelin acetate and gonadorelin acetate
Triptorelin acetate aqueous 0.1 mg/m2 subcutaneous. Gonadorelin acetate 100 ug intravenous.
(Active Comparator)
Patients undergo two test with a test interval of al least 15 days.
gonadorelin acetate and triptorelin acetate
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Primary Outcomes

Measure
LH
time frame: 3 hs
Estradiol
time frame: 24 hs

Secondary Outcomes

Measure
FSH
time frame: 3 hs

Eligibility Criteria

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.

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Hospital de Niños R. Gutierrez de Buenos Aires.