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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002471-11 | EudraCT Number |
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The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.
The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP.
The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration:
• Leuprorelin Acetate Depot 3M 11.25 mg
Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination.
This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprorelin Acetate Depot 3M 11.25 mg | Experimental | Participants with CPP having body weight greater than equal to (≥)20 kilograms (kg) received the recommended dose of leuprorelin acetate depot 11.25 milligrams (mg) subcutaneous administration (SC) every 12 weeks based on the standard of 30～180 micrograms (μg)/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin Acetate Depot 3M | Drug | Leuprorelin Acetate Depot 3M SC injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 | The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 | Tanner Stage was used to measure pubertal development. Tanner Stage was based on progression through 5-stages. The progression was defined as either breast/genitals or pubic hair score had increased score compared with baseline score. Otherwise, the status was classified as regression or no progression. Baseline is defined as the assessment prior to the first dose of study drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | Beijing Municipality | 100033 | China | ||
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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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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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.
Participants with a diagnosis of central precocious puberty (CPP) received leuprorelin acetate depot 11.25 milligrams (mg).
A total of 79 participants took part in the study at 5 investigative sites in China from 14 March 2023 to 10 March 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprorelin Acetate Depot 3M 11.25 mg | Participants with CPP having body weight greater than equal to (≥)20 kilograms (kg) received the recommended dose of leuprorelin acetate depot 11.25 mg subcutaneous administration (SC) every 12 weeks based on the standard of 30～180 micrograms (μg)/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprorelin Acetate Depot 3M 11.25 mg | Participants with CPP having body weight ≥20 kg received the recommended dose of leuprorelin acetate depot 11.25 mg SC every 12 weeks based on the standard of 30～180 μg/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 | The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L). | The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)
The safety population set included all included participants who had been under treatment with leuprorelin or who were first prescribed leuprorelin, received at least one dose and completed one follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leuprorelin Acetate Depot 3M 11.25 mg | Participants with CPP having body weight ≥20 kg received the recommended dose of leuprorelin acetate depot 11.25 mg SC every 12 weeks based on the standard of 30～180 μg/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Appendicitis | Infections and infestations | MedDRA28.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2022 | Dec 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2025 | Dec 19, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| Baseline and Week 24 |
| Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Plasma LH and FSH peak concentrations under GnRH stimulation were assessed. | Baseline, Weeks 24 and 36 |
| Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24 | Bone age was determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards. | Baseline and Week 24 |
| Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 | Baseline and Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an AE with an onset that occurs after receiving study drug. | From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks) |
| the First A liated Hospital of Sun Yat-sen University |
| Guangzhou |
| Guangdong |
| 510062 |
| China |
| The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University. | Wuhan | Hubei | 430030 | China |
| Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250021 | China |
| Shanghai Children's Hospital | Shanghai | Shanghai Municipality | 200062 | China |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 | Tanner Stage was used to measure pubertal development. Tanner Stage was based on progression through 5-stages. The progression was defined as either breast/genitals or pubic hair score had increased score compared with baseline score. Otherwise, the status was classified as regression or no progression. Baseline is defined as the assessment prior to the first dose of study drug. | The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Plasma LH and FSH peak concentrations under GnRH stimulation were assessed. | The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | Posted | Mean | Standard Deviation | IU/L | Baseline, Weeks 24 and 36 |
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| Secondary | Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24 | Bone age was determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards. | The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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|
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| Secondary | Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 | The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an AE with an onset that occurs after receiving study drug. | The safety population set included all included participants who had been under treatment with leuprorelin or who were first prescribed leuprorelin, received at least one dose and completed one follow-up visit. | Posted | Count of Participants | Participants | From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks) |
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| 0 |
| 79 |
| 1 |
| 79 |
| 4 |
| 79 |
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| LH: Week 36 |
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| FSH: Baseline |
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| FSH: Week 24 |
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| FSH: Week 36 |
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