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

What Was Tested

The trial (phase 3) is built around Gonadorelin and Triptorelin.

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.

It had two arms (groups): Triptorelin test AND LHRH test (active comparator) and LHRH test AND Triptorelin test (active comparator).

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

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

The registry classes the interventions as diagnostic test.

More on the Plan

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.

Who Took Part

The registry lists 46 actual participants took part.

It was open to women only aged from 3 years up to 8 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Premature thelarche and/or. Accelerated growth velocity (above 90 percentile). Advanced bone age at least 1.5 year in relation to chronological age.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Gonadorelin group and the comparison group should start out alike.

The Gonadorelin group and the comparison group ran side by side rather than switching.

Everyone knew when Gonadorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-12 with completion listed for 2011-06.

It ran at 1 site in Argentina.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: LH (time frame: 3 hs). Estradiol (time frame: 24 hs).

It also tracked 1 secondary outcome, for example FSH.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Gonadorelin and Triptorelin in 46 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Gonadorelin compound page and the Triptorelin compound page, all human trials.