Leuprorelin 1-Month in Children with Central Precocious Puberty
Official title: 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
Run by LG Chem · NCT07710430 · Data updated 2026-11-12
This study tests whether a 1-month formulation of leuprorelin can safely manage central precocious puberty in children over 24 months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 10 Years |
| Sex | All |
| Enrollment | 43 (estimated) |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | August 30, 2029 |
| Study ends | April 30, 2030 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07710430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are girls under 9 or boys under 10 who have been diagnosed with central precocious puberty and are at Tanner stage greater than or equal to 2.
✕Probably not a fit
Patients with GnRH-independent precocious puberty, brain tumors, hepatic or renal impairment, or other conditions requiring therapies affecting the HPG axis may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm, open-label, multicenter study evaluating the safety and effectiveness of a 1-month leuprorelin formulation in children with central precocious puberty over two years. Participants receive the drug as needed to suppress puberty-related hormones and are monitored for growth, development, and adverse events. The trial is conducted at multiple centers, led by LG Chem, to collect long-term data on outcomes and tolerability in a real-world-like setting.
Why it matters
Potential benefit: If successful, the treatment could provide a convenient, effective option for long-term puberty suppression in affected children.
How similar studies have gone: Previous studies of leuprorelin formulations have shown effectiveness in pubertal suppression, supporting continued evaluation with a 1-month formulation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Kangdong Sacred Heart Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Clinical Study Lead
- Email: lgclinical@lgchem.com
- Phone: 02-6987-4151
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.