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

Recruiting now · Phase 4

Conditions studied: Central Precocious Puberty

In brief

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

Key facts

Study ID

NCT07710430

Run by

LG Chem

People needed

43

Starts

2026-08-01

Expected to finish

2030-04-30

Last updated by the study team

2026-07-29

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Kangdong Sacred Heart Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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