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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2021 |
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Main ID: |
NCT01278290 |
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Date of registration:
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14/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
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Scientific title:
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Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls. |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01278290 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Maria G Ropelato, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina |
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Name:
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Analía V Freire, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
8 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Sexual Precocity
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Intervention(s)
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Diagnostic Test: Triptorelin acetate and Gonadorelin acetate
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Diagnostic Test: Gonadorelin acetate and Triptorelin acetate
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Primary Outcome(s)
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Estradiol
[Time Frame: 24 hs]
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LH
[Time Frame: 3 hs]
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Secondary Outcome(s)
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FSH
[Time Frame: 3 hs]
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Secondary ID(s)
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HNinosBuenosAires-Triptorelin
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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