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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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19 February 2015 |
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Main ID: |
NCT00438217 |
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Date of registration:
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21/02/2007 |
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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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Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
CPP-EDG 01 |
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Scientific title:
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Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00438217 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Francesco Massart, MD, PhD |
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Address:
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Telephone:
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+39-050-99-3600 |
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Email:
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massart@med.unipi.it |
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Affiliation:
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Name:
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Francesco Massart, MD, PhD |
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Address:
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Telephone:
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0039 050 99 3600 |
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Email:
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massart@med.unipi.it |
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Affiliation:
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Name:
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Giuseppe Saggese, 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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Department of Pediatrics, University of Pisa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinica diagnosis of central precocious puberty
- Diagnosis is based on growth spurt, bone age advancement, positive GnRH agonist
stimulating test, pubertal sex steroid levels before 8 years of age for female and 9
years for male, respectively
Exclusion Criteria:
- Thyroid disorders
- Peripheric diagnosis of precocious puberty
- Genetic disorders
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Intervention(s)
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Drug: Leuprolide (GnRH agonists)
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Drug: Triptorelin (GnRH agonists)
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Secondary ID(s)
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CPP-EDG 01
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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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