RecruitingNCT06720844
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
300 participants
Start Date
Mar 13, 2024
Study Type
OBSERVATIONAL
Conditions
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
Max Age: 18 Years
Inclusion Criteria5
- 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 Criteria3
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06720844