A Phase 4 interventional study of Leuprorelin in Central Precocious Puberty, sponsored by LG Chem. Recruiting at 1 site in South Korea. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by LG Chem · Phase 4, Interventional, and Treatment
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
75 studies on the registry are indexed under Puberty, Precocious; 18 are open to participants now.
This study's planned enrollment of 43 is below the median of 64 across 47 interventional studies indexed under Puberty, Precocious.
Browse Puberty, Precocious studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Leuprorelin
Leuprorelin will be administered every 4 weeks.
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Time frame: 24 weeks after treatment initiation
Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk
Time frame: 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)
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in pubertal development: Tanner stage
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: height in centimeter
Time frame: Up to 96 weeks after treatment initiation
Changes from baseline in growth related parameters: weight in kilograms
Time frame: Up to 96 weeks after treatment initiation
Safety: Number of participants with treatment-related adverse events as assessed by the investigator
Time frame: Up to 96 weeks after treatment initiation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
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Studies of the drug tested here: Leuprolide