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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2025-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

NCT02427958

Central Precocious Puberty

COMPLETED PHASE4

A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

NCT03695237

Central Precocious Puberty (CPP)

COMPLETED PHASE3

Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

NCT02452931

Precocious Puberty, Central

COMPLETED PHASE3

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

NCT05493709

Puberty; Precocious, Central

ACTIVE_NOT_RECRUITING PHASE3

Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty

NCT03316482

Central Precocious Puberty

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Precocious Puberty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 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.

Group Type EXPERIMENTAL

Leuprorelin Acetate Depot 3M

Intervention Type DRUG

Leuprorelin Acetate Depot 3M SC injections.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leuprorelin Acetate Depot 3M

Leuprorelin Acetate Depot 3M SC injections.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Leuprolide acetate Depot 3M

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
2. Body weight ≥20 kg
3. 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

1. The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
2. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
3. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
4. The participant has a diagnosis of peripheral precocious puberty.

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No