Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics

March 11, 2026 updated by: Federico Baronio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Observational, retrosopective, single-centre, non-profit study focused on the frequency of Central Precocious Puberty idiopathic, or associated to Neurodevelopmental Syndromes and Pathologies, and comparison of diagnostic and developmental characteristics of patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study enrolls both male and female patients referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola between 01/01/2013 and 31/12/2023 for Central Precocious Puberty and treated with GnRH analouge. The primary aim of the study is to Assess the frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty in the last decade. The secondary aims are to Compare clinical, laboratory and instrumental characteristics at diagnosis and in follow-up between patients with idiopathic and syndromic PPC, and to identifying possible pathogenetic factors characterising different forms of Central Precocious Puberty.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Bolgona
      • Bologna, Bolgona, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
        • Principal Investigator:
          • Federico Baronio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All male and female patients referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola between 01/01/2013 and 31/12/2023 for Central Precocious Puberty and treated with GnRH analouge.

Description

Inclusion Criteria:

  • Patients diagnosed with Central Precocious Puberty presenting an indication to undertake treatment with GnRH analogue: Appearance of secondary sexual characteristics (thelarche or gonadarche) before the age of 8 for females and 9 for males; Acceleration of the rate of statural growth and advancement of bone age one year older than the chronological age; LH peak > 5 IU/L on GnRH test and a longitudinal uterine diameter > 36 mm in females, with or without the appearance of endometrial rhyme;
  • Age at onset of entral Precocious Puberty between 2 and 8 years (females) or between 2 and 9 years (males);
  • Age at enrollment < 18 years;
  • Follow-up of at least 12 months;
  • Obtaining informed consent from parents/legal guardian of peduatric patients.

Exclusion Criteria:

  • Isolated telarche and/or pubarche;
  • Peripheral forms of precocious puberty;
  • Patients diagnosed with primary organic Central Precocious Puberty due to tumour- or non-tumour-causing hypothalamic lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty
Time Frame: at baseline
diagnosis of idiopathic or syndromic Central Precocious Puberty
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Federico Baronio, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

March 13, 2027

Study Completion (Estimated)

May 13, 2027

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR-PPC23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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