Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Recruitment status was: Active, not recruiting
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
|Central Precocious Puberty Sexual Precocity||Drug: Triptorelin acetate and Gonadorelin acetate Drug: Gonadorelin acetate and Triptorelin acetate||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.|
- 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.
- 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.
- 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.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Triptorelin test AND LHRH test
Patients undergo two tests with a test interval of at least 15 days
Drug: Triptorelin acetate and Gonadorelin acetate
Triptorelin acetate aqueous 0.1 mg/m2 subcutaneous. Gonadorelin acetate 100 ug intravenous.
Active Comparator: LHRH test AND Triptorelin test
Patients undergo two test with a test interval of al least 15 days.
Drug: Gonadorelin acetate and Triptorelin acetate
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278290
|Hospital de Niños Ricardo Gutierrez, División de Endocrinología|
|Ciudad Autónoma de Buenos Aires, Argentina, C1425SEFD|
|Study Director:||Maria G Ropelato, PhD||División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina|
|Principal Investigator:||Analía V Freire, MD||División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina|