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

Last updated: March 11, 2026
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06720844
SDR-PPC23
  • Ages < 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with Central Precocious Puberty presenting an indication toundertake treatment with GnRH analogue: Appearance of secondary sexualcharacteristics (thelarche or gonadarche) before the age of 8 for females and 9 formales; Acceleration of the rate of statural growth and advancement of bone age oneyear older than the chronological age; LH peak > 5 IU/L on GnRH test and alongitudinal uterine diameter > 36 mm in females, with or without the appearance ofendometrial 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

Exclusion Criteria:

  • Isolated telarche and/or pubarche;

  • Peripheral forms of precocious puberty;

  • Patients diagnosed with primary organic Central Precocious Puberty due to tumour- ornon-tumour-causing hypothalamic lesions.

Study Design

Total Participants: 300
Study Start date:
March 13, 2024
Estimated Completion Date:
May 13, 2027

Study 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.

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bolgona 40138
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.