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

University of Pisa

Status and phase: Unknown; Phase 4

Conditions: Central Precocious Puberty

Treatments: Drug: Leuprolide (GnRH agonists); Drug: Triptorelin (GnRH agonists)

Study type: Interventional

Funder types: Other

Identifiers

NCT00438217

CPP-EDG 01

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)