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CPP-EDG 01: Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Sponsor
University of Pisa (Other)
Overall Status
Unknown status
CT.gov ID
NCT00438217
Collaborator
(none)
100
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. In this view, we are collecting clinical data and biological samples of children attended as outpatients at the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different GnRH agonists.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triptorelin (GnRH agonists)
  • Drug: Leuprolide (GnRH agonists)
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa Pisa Italy 56125

    Sponsors and Collaborators

    • University of Pisa

    Investigators

    • Study Director: Giuseppe Saggese, MD, Department of Pediatrics, University of Pisa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00438217
    Other Study ID Numbers:
    • CPP-EDG 01
    First Posted:
    Feb 22, 2007
    Last Update Posted:
    Feb 22, 2007
    Last Verified:
    Feb 1, 2007
    Keywords provided by , ,
    precocious puberty, genetics, environmental factors
    Additional relevant MeSH terms:
    Puberty, Precocious
    Leuprolide
    Triptorelin Pamoate
    Prolactin Release-Inhibiting Factors

    Study Results

    No Results Posted as of Feb 22, 2007