A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)

Conditions
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Central Precocious Puberty

Intervention / Treatment
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* Drug: Leuprorelin Acetate Depot 3M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years Body weight ≥20 kg According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level >5.0 IU/L with LH/FSH >0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening. Exclusion Criteria: The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. The participant has a diagnosis of peripheral precocious puberty.

Ages Eligible for Study
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Maximum Age: 9 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: Leuprorelin Acetate Depot 3M 11.25 mg<br>Participants with CPP having body weight ≥20 kg will receive the recommended dose of leuprorelin acetate depot 11.25 mg subcutaneous administration (SC) every 12 weeks based on the standard of 30～180ug/kg/4weeks for the 24-week Treatment Period. It is not recommended to exceed the dose above 180 μg/kg. | Drug: Leuprorelin Acetate Depot 3M<br>* Leuprorelin Acetate Depot 3M SC injections.<br>* Other names: Leuprolide acetate Depot 3M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 is defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L). | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Tanner Stage Regression or No Progression at Week 24 | Tanner Stage is used to measure pubertal development. Tanner Stage is based on progression through 5-stages. The progression was defined that 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. | Baseline and Week 24 | 
| Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Plasma LH and FSH peak concentrations under GnRH stimulation will be assessed. | Baseline, Week 24 and 36 | 
| Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24 | Bone age will be 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 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 adverse event 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 38 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy