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

Phase 3

Completed

• Conditions: Central Precocious Puberty; Sexual Precocity
• Interventions: Diagnostic Test: Gonadorelin acetate and Triptorelin acetate; Diagnostic Test: Triptorelin acetate and Gonadorelin acetate

• Registration Number: NCT01278290
• Lead Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Brief 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).

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LHRH test AND Triptorelin test	Gonadorelin acetate and Triptorelin acetate	Patients undergo two test with a test interval of al least 15 days.
Triptorelin test AND LHRH test	Triptorelin acetate and Gonadorelin acetate	Patients undergo two tests with a test interval of at least 15 days

Primary Outcome Measures

Name	Time	Method
Estradiol	24 hs	Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
LH	3 hs	Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Secondary Outcome Measures

Name	Time	Method
FSH	3 hs	Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Trial Locations

Locations (1)

Hospital de Niños Ricardo Gutierrez, División de Endocrinología; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina