Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children - Full Text View

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

This study is currently recruiting participants.

Verified by University of Pisa, February 2007

First Received: February 21, 2007 No Changes Posted

Sponsored by:	University of Pisa
Information provided by:	University of Pisa
ClinicalTrials.gov Identifier:	NCT00438217

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 IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Resource links provided by NLM:

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Leuprolide Triptorelin Triptorelin pamoate LH-RH

U.S. FDA Resources

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

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

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

Keywords provided by University of Pisa:

precocious puberty, genetics, environmental factors

Study placed in the following topic categories:

Deslorelin
Antineoplastic Agents, Hormonal
Contraceptive Agents
Triptorelin
Leuprolide
Gonadal Disorders

Puberty, Precocious
Contraceptive Agents, Female
Precocious Puberty
Endocrine System Diseases
Endocrinopathy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Puberty, Precocious
Gonadal Disorders
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female

Endocrine System Diseases
Enzyme Inhibitors
Reproductive Control Agents
Luteolytic Agents
Pharmacologic Actions
Deslorelin
Triptorelin
Therapeutic Uses

ClinicalTrials.gov processed this record on September 10, 2009