NCT05341128

Brief Summary

The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them. There are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

April 18, 2022

Last Update Submit

January 16, 2026

Conditions

Keywords

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With CPP Treatment

    Up to approximately 10 years

Secondary Outcomes (3)

  • Percentage of Participants With CPP Treatment at Baseline

    At Baseline

  • Percentage of Participants With Luteinizing hormone (LH) Suppression

    Baseline up to approximately 10 years

  • Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Up to approximately 10 years

Study Arms (1)

All Participants With CPP

Pediatric participants who have been diagnosed with CPP, who are currently or previously undergoing with gonadotropin-releasing hormone agonist (GnRHa) treatment between 2015, and 31 December 2024 will be assessed retrospectively using the Chinese CPP Big Data Platform database.

Eligibility Criteria

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

Pediatric participants with a diagnosis of CPP who are currently or previously undergoing GnRHa treatment between 2015 and 31 December 2024 will be enrolled in this study.

You may qualify if:

  • Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to 2024.
  • CPP diagnosis is based on the clinical assessment and description by CPP specialized doctors.

You may not qualify if:

  • Not received GnRHa as the treatment for CPP.
  • No available data for analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530007, China

Location

Hainan Women and Children's Medical Center

Haikou, Hainan, 570206, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Links

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 22, 2022

Study Start

December 13, 2023

Primary Completion

August 27, 2025

Study Completion

August 27, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations