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Completed

NCT Number: NCT01278290

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

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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Key information

Conditions

Central Precocious Puberty Endocrine System Diseases Gonadal Disorders Puberty, Precocious Sexual Precocity

Age range

3 year–8 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Niños Ricardo Gutierrez, División de Endocrinología

Buenos Aires, C1425SEFD, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triptorelin acetate and Gonadorelin acetate

Diagnostic Test

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

Gonadorelin acetate and Triptorelin acetate

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2011
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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