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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Central Precocious Puberty, Sexual Precocity

Intervention / Treatment
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* Diagnostic Test: Triptorelin acetate and Gonadorelin acetate
* Diagnostic Test: Gonadorelin acetate and Triptorelin acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triptorelin test AND LHRH test<br>Patients undergo two tests with a test interval of at least 15 days | Diagnostic Test: Triptorelin acetate and Gonadorelin acetate<br>* Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.<br>|
| Active Comparator: LHRH test AND Triptorelin test<br>Patients undergo two test with a test interval of al least 15 days. | Diagnostic Test: Gonadorelin acetate and Triptorelin acetate<br>* Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH | Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation. | 3 hs | 
| Estradiol | Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation. | 24 hs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH | Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation. | 3 hs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study