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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

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

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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).

Conditions

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Central Precocious Puberty Sexual Precocity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Triptorelin test AND LHRH test

Patients undergo two tests with a test interval of at least 15 days

Group Type ACTIVE_COMPARATOR

Triptorelin acetate and Gonadorelin acetate

Intervention Type DIAGNOSTIC_TEST

Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.

LHRH test AND Triptorelin test

Patients undergo two test with a test interval of al least 15 days.

Group Type ACTIVE_COMPARATOR

Gonadorelin acetate and Triptorelin acetate

Intervention Type DIAGNOSTIC_TEST

Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Interventions

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Triptorelin acetate and Gonadorelin acetate

Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.

Intervention Type DIAGNOSTIC_TEST

Gonadorelin acetate and Triptorelin acetate

Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No