A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China

NCT ID: NCT05341128

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1477 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2025-08-27

Brief Summary

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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.

Detailed Description

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This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP.

This study will enroll approximately 1000 participants.

The data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort:

• Pediatric Participants With CPP

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.

Conditions

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Central Precocious Puberty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

• 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.

Exclusion Criteria

* Not received GnRHa as the treatment for CPP.
* No available data for analysis.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status

Hainan Women and Children's Medical Center

Haikou, Hainan, China

Site Status

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

Wuhan, Hubei, China

Site Status

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Related Links

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https://clinicaltrials.takeda.com/study-detail/88f831d40d9d43b3??page=1&idFilter=Leuprorelin-5007

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Other Identifiers

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Leuprorelin-5007

Identifier Type: -

Identifier Source: org_study_id

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