Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01278290
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2011-01-14
Brief Title:
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Sponsor:
Hospital de Niños R Gutierrez de Buenos Aires
Organization:
Hospital de Niños R Gutierrez de Buenos Aires
Study Overview
Official Title:
Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty CPP in Girls
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None