Central Precocious Puberty
Conditions
Brief 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
Interventions
DRUGLeuprorelin
Leuprorelin will be administered every 4 weeks.
Sponsors
LG Chem
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) | 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 | Up to 96 weeks after treatment initiation |
| Changes from baseline in growth related parameters: 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 |
Countries
South Korea
Contacts
CONTACTClinical Study Lead
Outcome results
None listed