MedTrace Logo

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

NCT01278290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-01-06

No results posted yet for this study

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

Conditions

  • Central Precocious Puberty
  • Sexual Precocity

Interventions

DIAGNOSTIC_TEST

Triptorelin acetate and Gonadorelin acetate

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

DIAGNOSTIC_TEST

Gonadorelin acetate and Triptorelin acetate

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

Sponsors & Collaborators

  • Hospital de Niños R. Gutierrez de Buenos Aires

    lead OTHER

Principal Investigators

  • Maria G Ropelato, PhD · División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina

  • Analía V Freire, MD · División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278290 on ClinicalTrials.gov