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

Overview

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

Full Title of Study: “Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Triptorelin test AND LHRH test
    • Patients undergo two tests with a test interval of at least 15 days
  • Active Comparator: LHRH test AND Triptorelin test
    • Patients undergo two test with a test interval of al least 15 days.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 3 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Niños R. Gutierrez de Buenos Aires
  • Provider of Information About this Clinical Study
    • Principal Investigator: Analía Freire, Pediatric Endocrinology, PhD – Hospital de Niños R. Gutierrez de Buenos Aires
  • Overall Official(s)
    • Maria G Ropelato, PhD, Study Director, División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina
    • Analía V Freire, MD, Principal Investigator, División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina

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