Evaluate the Efficacy and Safety of DWJ108J

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.

Detailed Description
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The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.

Official Title
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A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study

Conditions
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Central Precocious Puberty

Intervention / Treatment
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* Drug: Leuprolide Acetate 11.25 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening Diagnosis of central precocious puberty For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent Exclusion Criteria: Following conditions at Visit 1(Screening) : Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis Prior treatment with GnRH analogues Hypersensitive to the investigational drug for this clinical trial or GnRH analogues Prior or current therapy with growth hormone has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine Meets the following criteria based on screening test results: AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Leuprorelin<br>Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months. | Drug: Leuprolide Acetate 11.25 MG/ML<br>* Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months. | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L. | 3 months | 
| Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration. | Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration. | Baseline, 3 and 6 months | 
| Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration | Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration | 3 and 6 months | 
| Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration. | Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration. | Baseline, 3 and 6 months | 
| Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration. | Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration. | 6 months | 
| Average Tanner Stage at 6 months after administration, and the changes compared to before administration. | Average Tanner Stage at 6 months after administration, and the changes compared to before administration. | 6 months | 
| Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration. | Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration. | 6 months |