Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

Completed

• Conditions: Central Precocious Puberty (CPP)

• Registration Number: NCT06720623
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This is an observational, retrospective, single-center study focused on the diagnosis of Central Precocious Puberty in female patients.

Detailed Description

The study enrolls female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020 at the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola.

The study design provides 2 cohorts of female patients on the basis of the LH peak value in GnRH test: patients with LH peak value \< 5U/L, and patients with LH peak value \> 5U/L.

The primary aim is to assess the diagnostic power of basal LH comparing with the LH peak value after stimulus test with GnRH in female patients with suspected precocious puberty. The secondary aim is to assess the association of the following variables between the two cohorts: uterine volume, longitudinal uterine diameter, presence of endometrial rhyme, ratio of peak LH/FSH values and dose per kg of GnRH administered during stimulus test.

Study Timeline

• Study Start: 2021-05-25
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

• Female patients with onset of signs of early pubertal development (onset of telarche) before the age of 8 years, who referred to the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola between January 2017 and December 2020;
• Female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020;
• Obtaining informed consent from parents/legal guardian of pediatric patients.

Exclusion Criteria

• Patients with Peripheral precocious puberty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LH value	at baseline	basal Lh value, and LH peak value after stimulus test with GnRH (mU/mL )

Secondary Outcome Measures

Name	Time	Method
Uterine volume	at baseline	ml
Longitudinal uterine diameter	at baseline	mm
Presence of endometrial rhyme	at baseline	yes/no
Ratio of peak LH/FSH values	at baseline	peak LH (mU/mL) value / FSH value ( mU/mL)
peak LH (mU/mL) value / FSH value ( mU/mL)	at baseline	mcg/kg

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy