Central Precocious PubertyPACTURENCT05341128
A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
An observational study of Central Precocious Puberty, run by Takeda at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Central Precocious Puberty
- How many people
- 1,477 participants
- Where
- 5 sitesChina
- Study dates
- 13 Dec 2023to 27 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Not received GnRHa as the treatment for CPP.
- No available data for analysis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hainan Women and Children's Medical Center
Haikou, Hainan, 570206
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
About this study
Official title: Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
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.
Read the detailed description
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
- Central Precocious Puberty
- Keywords
- Central Precocious Puberty
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With CPP Treatment
Measured: Up to approximately 10 years
Secondary outcomes (3)
Percentage of Participants With CPP Treatment at Baseline
Measured: At Baseline
Percentage of Participants With Luteinizing hormone (LH) Suppression
Measured: Baseline up to approximately 10 years
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start13 Dec 2023
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341128
- Sponsor's protocol ID
- Leuprorelin-5007
- Acronym
- PACTURE
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
- ClinicalTrials.gov ID
- NCT05341128
- Acronym / sponsor ID
- PACTURE / Leuprorelin-5007
- Conditions
- Central Precocious Puberty
- Keywords
- Central Precocious Puberty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,477 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Not received GnRHa as the treatment for CPP.
- No available data for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With CPP Treatment
Time frame: Up to approximately 10 years
3 secondary outcomes
Percentage of Participants With CPP Treatment at Baseline
Time frame: At Baseline
Percentage of Participants With Luteinizing hormone (LH) Suppression
Time frame: Baseline up to approximately 10 years
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Precocious Puberty, run by Takeda at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With CPP Treatment (time frame: Up to approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.