Back to resultsComparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Primary Purpose
Central Precocious Puberty, Sexual Precocity
Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Triptorelin acetate and Gonadorelin acetate
Gonadorelin acetate and Triptorelin acetate
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Precocious Puberty focused on measuring Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study
Eligibility Criteria
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.
Sites / Locations
- Hospital de Niños Ricardo Gutierrez, División de Endocrinología
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Triptorelin test AND LHRH test
LHRH test AND Triptorelin test
Arm Description
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.
Outcomes
Primary Outcome Measures
LH
Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Estradiol
Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Secondary Outcome Measures
FSH
Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Full Information
NCT ID
NCT01278290
First Posted
January 14, 2011
Last Updated
January 4, 2021
Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT01278290
Brief Title
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Official Title
Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Precocious Puberty, Sexual Precocity
Keywords
Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptorelin test AND LHRH test
Arm Type
Active Comparator
Arm Description
Patients undergo two tests with a test interval of at least 15 days
Arm Title
LHRH test AND Triptorelin test
Arm Type
Active Comparator
Arm Description
Patients undergo two test with a test interval of al least 15 days.
Intervention Type
Diagnostic Test
Intervention Name(s)
Triptorelin acetate and Gonadorelin acetate
Intervention Description
Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gonadorelin acetate and Triptorelin acetate
Intervention Description
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
Primary Outcome Measure Information:
Title
LH
Description
Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Time Frame
3 hs
Title
Estradiol
Description
Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Time Frame
24 hs
Secondary Outcome Measure Information:
Title
FSH
Description
Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Time Frame
3 hs
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria G Ropelato, PhD
Organizational Affiliation
División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Analía V Freire, MD
Organizational Affiliation
División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Niños Ricardo Gutierrez, División de Endocrinología
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1425SEFD
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
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