NCT00438217

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
Last Updated

February 22, 2007

Status Verified

February 1, 2007

First QC Date

February 21, 2007

Last Update Submit

February 21, 2007

Conditions

Central Precocious Puberty

Keywords

precocious puberty, genetics, environmental factors

Interventions

Triptorelin (GnRH agonists)DRUG
Leuprolide (GnRH agonists)DRUG

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Thyroid disorders
  • Peripheric diagnosis of precocious puberty
  • Genetic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa

Pisa, 56125, Italy

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Triptorelin PamoateLeuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Giuseppe Saggese, MD

    Department of Pediatrics, University of Pisa

    STUDY DIRECTOR

Central Study Contacts

Francesco Massart, MD, PhD

CONTACT

0039 050 99 3600massart@med.unipi.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Last Updated

February 22, 2007

Record last verified: 2007-02

Locations

IT(1)