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Completed

NCT Number: NCT06720623

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

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

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Key information

Conditions

Central Precocious Puberty (CPP) Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Age range

Up to 8 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. LH value

    Time frame: at baseline

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

Secondary outcomes

  1. Uterine volume

    Time frame: at baseline

    ml

  2. Longitudinal uterine diameter

    Time frame: at baseline

    mm

  3. Presence of endometrial rhyme

    Time frame: at baseline

    yes/no

  4. Ratio of peak LH/FSH values

    Time frame: at baseline

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

  5. peak LH (mU/mL) value / FSH value ( mU/mL)

    Time frame: at baseline

    mcg/kg

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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