Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children (CPP-EDG 01)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University of Pisa.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Pisa
Information provided by:
University of Pisa
ClinicalTrials.gov Identifier:
NCT00438217
First received: February 21, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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:
Genetics Home Reference related topics:
familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
Drug Information available for:
Gonadorelin
Gonadorelin hydrochloride
Deslorelin
Leuprolide acetate
Triptorelin pamoate
U.S. FDA Resources
Further study details as provided by University of Pisa:
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
| ClinicalTrials.gov Identifier: | NCT00438217 History of Changes |
| Other Study ID Numbers: | CPP-EDG 01 |
| Study First Received: | February 21, 2007 |
| Last Updated: | February 21, 2007 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by University of Pisa:
|
precocious puberty, genetics, environmental factors |
Additional relevant MeSH terms:
|
Puberty, Precocious Gonadal Disorders Endocrine System Diseases Triptorelin Leuprolide Deslorelin Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 19, 2013