A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Leuprorelin.
- Who it may be relevant to
- Registry conditions: Central Precocious Puberty. Basic parameters: up to 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Leuprorelin
Leuprorelin will be administered every 4 weeks.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Kangdong Sacred Heart Hospital — Seoul
Identifiers
NCT: NCT07710430 · LG-LPLCL001