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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprorelin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin | Drug | Leuprorelin will be administered every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L). | 24 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Lead | Contact | 02-6987-4151 | lgclinical@lgchem.com |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Up to 96 weeks after treatment initiation |
| Changes from baseline in pubertal development: Tanner stage | Up to 96 weeks after treatment initiation |
| Changes from baseline in growth related parameters: height in centimeter, weight in kilograms | Up to 96 weeks after treatment initiation |
| Safety: Number of participants with treatment-related adverse events as assessed by the investigator | Up to 96 weeks after treatment initiation |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |