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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278290

Enrollment

Registered

2011-01-17

Start date

2009-12-31

Completion date

2011-06-30

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Precocious Puberty, Sexual Precocity

Keywords

Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study

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).

Interventions

DIAGNOSTIC_TESTTriptorelin acetate and Gonadorelin acetate

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

DIAGNOSTIC_TESTGonadorelin acetate and Triptorelin acetate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

3 Years to 8 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026