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Trial record 13 of 147 for:    puberty

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University of Pisa.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pisa
ClinicalTrials.gov Identifier:
NCT00438217
First received: February 21, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Central Precocious Puberty
Drug: Triptorelin (GnRH agonists)
Drug: Leuprolide (GnRH agonists)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Resource links provided by NLM:


Further study details as provided by University of Pisa:

Estimated Enrollment: 100
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438217

Contacts
Contact: Francesco Massart, MD, PhD 0039 050 99 3600 ext 2950 massart@med.unipi.it

Locations
Italy
Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa Recruiting
Pisa, Italy, 56125
Contact: Francesco Massart, MD, PhD    +39-050-99-3600 ext 2950    massart@med.unipi.it   
Sponsors and Collaborators
University of Pisa
Investigators
Study Director: Giuseppe Saggese, MD Department of Pediatrics, University of Pisa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00438217     History of Changes
Other Study ID Numbers: CPP-EDG 01
Study First Received: February 21, 2007
Last Updated: February 21, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by University of Pisa:
precocious puberty, genetics, environmental factors

Additional relevant MeSH terms:
Puberty, Precocious
Endocrine System Diseases
Gonadal Disorders
Deslorelin
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014