Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Estradiol
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 8 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- FSH(3 hs)
Investigators
Analía Freire
Pediatric Endocrinology, PhD
Hospital de Niños R. Gutierrez de Buenos Aires