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Clinical Trials/NCT07710430
NCT07710430RecruitingPhase 4

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

LG Chem1 site in 1 country43 target enrollmentStarted: August 1, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
43
Locations
1
Primary Endpoint
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Leuprorelin

Experimental

Intervention: Leuprorelin (Drug)

Outcomes

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

  • 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, 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)
  • 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 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)

Investigators

Sponsor
LG Chem
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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