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

NCT06720623 | Completed

• 1 other identifier: LuteoTest
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Precocious Puberty (CPP)

Keywords

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• LH value

  basal Lh value, and LH peak value after stimulus test with GnRH (mU/mL )

  at baseline

Secondary Outcomes (5)

• Uterine volume

  at baseline

• Longitudinal uterine diameter

  at baseline

• Presence of endometrial rhyme

  at baseline

• Ratio of peak LH/FSH values

  at baseline

• peak LH (mU/mL) value / FSH value ( mU/mL)

  at baseline

Eligibility Criteria

• Age: Up to 8 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with Peripheral precocious puberty.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Related Links

• PubMed article "Does Basal Morning Luteinizing Hormone (bLH) Predict Central Precocious Puberty (CPP) in Girls?"

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Federico Baronio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: May 25, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-10

Locations

IT (1)