A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty

July 13, 2026 updated by: LG Chem

A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty

A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Tanner stage =>2
  2. Girls younger than 9 years old, boys younger than 10 years old
  3. Subjects who are diagnosed with central precocious puberty (CPP)

Exclusion Criteria:

  1. GnRH-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma
  2. Hepatic impairment or abnormal liver function tests at screening
  3. Renal impairment or abnormal renal function at screening
  4. Use of following within 8 weeks prior to screening or during the study: medications affecting gonadotropin or sex hormone, systemic steroids, herbal medications
  5. Use of medications associated with seizures
  6. Requirement for treatments affecting the hypothalamic-pituitary-gonadal axis
  7. History of seizures, epilepsy, cerebrovascular disease, or central nervous system disorders/tumors
  8. Known or suspected malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leuprorelin
Drug: Leuprorelin
Leuprorelin will be administered every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Time Frame: 24 weeks after treatment initiation
24 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk
Time Frame: 48 weeks and 96 weeks after treatment initiation
48 weeks and 96 weeks after treatment initiation
Changes from baseline in endocrine function: basal LH in IU/L, follicle-stimulating hormone (FSH) in IU/L, testosterone (T) in nanograms per deciliter (ng/dL), estradiol (E2) in picograms per milliliter (pg/mL)
Time Frame: Up to 96 weeks after treatment initiation
Up to 96 weeks after treatment initiation
Changes from baseline in pubertal development: Tanner stage
Time Frame: Up to 96 weeks after treatment initiation
Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: height in centimeter, weight in kilograms
Time Frame: Up to 96 weeks after treatment initiation
Up to 96 weeks after treatment initiation
Safety: Number of participants with treatment-related adverse events as assessed by the investigator
Time Frame: Up to 96 weeks after treatment initiation
Up to 96 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-LPLCL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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