RecruitingPhase 4

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

South Korea43 participantsStarted 2026-08-01

Plain-language 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

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 weeks after treatment initiation

Trial details

NCT IDNCT07710430

SponsorLG Chem

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-08-30

Contact for this trial

Clinical Study Lead

02-6987-4151 lgclinical@lgchem.com

View on ClinicalTrials.gov More Central Precocious Puberty trials