Central Precocious PubertyPhase 4CPP-EDG 01NCT00438217
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
A Phase 4 study testing Triptorelin (GnRH agonists) and Leuprolide (GnRH agonists) in people with Central Precocious Puberty, run by University of Pisa at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Precocious Puberty
- What is being tested?
- Triptorelin (GnRH agonists) and Leuprolide (GnRH agonists)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Thyroid disorders
- Peripheric diagnosis of precocious puberty
- Genetic disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Center of Pediatric endocrinology, Department of Pediatrics, University of Pisa
Pisa, 56125
Francesco Massart, MD, PhD, +39-050-99-3600 ext. 2950, massart@med.unipi.it
About this study
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.
- Conditions
- Central Precocious Puberty
- Being tested
- Triptorelin (GnRH agonists), Leuprolide (GnRH agonists)
- Keywords
- precocious puberty, genetics, environmental factors
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin (GnRH agonists)Drug
Leuprolide (GnRH agonists)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Saggese, MD, Study director, Department of Pediatrics, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438217
- Sponsor's protocol ID
- CPP-EDG 01
- Acronym
- CPP-EDG 01
- Status last verified
- Feb 2007
- First submitted
- 21 Feb 2007
- Last updated
- 22 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
- ClinicalTrials.gov ID
- NCT00438217
- Acronym / sponsor ID
- CPP-EDG 01 / CPP-EDG 01
- Conditions
- Central Precocious Puberty
- Keywords
- precocious puberty, genetics, environmental factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- University of PisaUniversity, hospital or other
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Thyroid disorders
- Peripheric diagnosis of precocious puberty
- Genetic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin (GnRH agonists) | Drug | – |
| Leuprolide (GnRH agonists) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Saggese, MD study director
Department of Pediatrics, University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptorelin (GnRH agonists) and Leuprolide (GnRH agonists) in people with Central Precocious Puberty, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Massart, MD, PhD (0039 050 99 3600 ext. 2950, massart@med.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2007.