NCT06823076

Brief Summary

Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

February 11, 2025

Last Update Submit

February 11, 2025

Conditions

Keywords

Central precocious puberty, COVID-19 pandemic, GnRH analogs, pediatric endocrinology, lifestyle changes

Outcome Measures

Primary Outcomes (1)

  • Mean Age at Pubertal Onset

    Mean Age at Pubertal Onset Description: The mean age at pubertal onset will be compared between pre-pandemic and post-pandemic periods in both girls and boys. Time Frame: At baseline. Method of Measurement: Tanner staging, LH/FSH levels, and bone age assessment.

    4 years

Study Arms (1)

prepandemic and pandemic precocious puberty groups were compared

Eligibility Criteria

AgeUp to 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study included patients admitted to the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital and Suleyman Demirel University, located in two different cities in Turkey. These patients were diagnosed with precocious puberty and treated with GnRH analogs before and after the COVID-19 pandemic. The patients were categorized into two groups: the pre-pandemic group (admitted and started GnRH analog treatment between March 2018 and March 2020) and the pandemic group (admitted and started GnRH analog treatment between March 2020 and March 2022), covering 24 months before and after the start of the pandemic lockdown

You may qualify if:

  • Girls: Tanner stage ≥2 before age 8 peak LH \> on gnrh analog test, basal Lh \>0,3
  • Patients with organic lesions (e.g., hypothalamo-pituitary tumors), congenital malformations, oncological diseases, neurosurgical or genetic disorders, or medications affecting puberty were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital

Istanbul, Istanbul, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Puberty, PrecociousCOVID-19

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
4 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 12, 2025

Study Start

March 1, 2018

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

February 12, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Only aggregated study results will be published in peer-reviewed journals."

Locations