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Clinical Trials in South Korea / NCT07710430
Recruiting Phase 4

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

NCT07710430 · tracked via the Priya Life Science South Korea tracker
Sponsor
LG Chem
Phase
Phase 4
Started
2026-08-01
Last updated
2026-07-29

Condition(s) studied

Central Precocious Puberty

Investigational drug(s) / intervention(s)

Leuprorelin →

Leuprorelin: Leuprorelin will be administered every 4 weeks.

Study 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

Eligibility

Sex
ALL
Min age
—
Max age
10 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Kangdong Sacred Heart Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07710430 on ClinicalTrials.gov ↗ ← All trials in South Korea