A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty

NCTNCT07710430Other idLG-LPLCL001

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Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 43 participants (estimated)
Sponsor: LG Chem · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
South Korea
Start: 1 Aug 2026 (estimated)
Primary completion: 30 Aug 2029 (estimated)
Completion: 30 Apr 2030 (estimated)
First posted: 17 Jul 2026
Last update posted: 29 Jul 2026
Conditions: Central Precocious Puberty

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028202920302031

Ph 4
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
NCT07710430
est. 1 Aug 2026 to est. 30 Apr 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

LeuprorelinDrug

Arms1

Experimental
Leuprorelin

Primary outcomes1

Outcomes the sponsor listed as primary.

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(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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: up to 10 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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