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

NCT07710430 | Recruiting Phase 4

• 1 other identifier: LG-LPLCL001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).

  24 weeks after treatment initiation

Secondary Outcomes (6)

• Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk

  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)

  Up to 96 weeks after treatment initiation

• Changes from baseline in pubertal development: Tanner stage

  Up to 96 weeks after treatment initiation

• Changes from baseline in growth related parameters: height in centimeter

  Up to 96 weeks after treatment initiation

• Changes from baseline in growth related parameters: weight in kilograms

  Up to 96 weeks after treatment initiation

Study Arms (1)

Leuprorelin

EXPERIMENTAL

Drug: Leuprorelin

Interventions

Leuprorelin DRUG

Leuprorelin will be administered every 4 weeks.

Leuprorelin

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Clinical Study Lead

CONTACT

02-6987-4151; lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)