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

January 4, 2021 updated by: Analía Freire, Hospital de Niños R. Gutierrez de Buenos Aires

Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, C1425SEFD
        • Hospital de Niños Ricardo Gutierrez, División de Endocrinología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hs
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.
24 hs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Investigators

  • Study Director: Maria G Ropelato, PhD, División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
  • Principal Investigator: Analía V Freire, MD, División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNinosBuenosAires-Triptorelin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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