Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Central Precocious Puberty Clinical Trial

— CPP-EDG 01  

Official title:

Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00438217
• Other study ID #: CPP-EDG 01
• Status: Recruiting
• Phase: Phase 4
• First received: February 21, 2007
• Last updated: February 21, 2007

Study information

• Verified date: February 2007
• Source: University of Pisa
• Contact: Francesco Massart, MD, PhD
• Phone: 0039 050 99 3600
• Email: massart[@]med.unipi.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Triptorelin (GnRH agonists)

• Leuprolide (GnRH agonists)

Locations

Country	Name	City	State
Italy	Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy,