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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by University of Pisa.
Recruitment status was:  Recruiting
Information provided by:
University of Pisa Identifier:
First received: February 21, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
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
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

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
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
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Please refer to this study by its identifier: NCT00438217

Contact: Francesco Massart, MD, PhD 0039 050 99 3600 ext 2950

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   
Sponsors and Collaborators
University of Pisa
Study Director: Giuseppe Saggese, MD Department of Pediatrics, University of Pisa
  More Information Identifier: NCT00438217     History of Changes
Other Study ID Numbers: CPP-EDG 01
Study First Received: February 21, 2007
Last Updated: February 21, 2007

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

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents processed this record on May 23, 2017