DRUG
Leuprorelin
Leuprorelin will be administered every 4 weeks.
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
Status
Recruiting
Phase
Phase 4
Enrollment
43
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 17, 2026
Study start
Aug 1, 2026
Primary completion
Aug 30, 2029
Study completion
Apr 30, 2030
Results posted
Not reported
Registry updated
Jul 29, 2026
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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
Who can take part.
- Minimum age
- Not reported
- Maximum age
- 10 Years
- Sex
- ALL
- 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
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Kangdong Sacred Heart Hospital
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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