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

Phase 4RecruitingNCT07710430

LG Chem43 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Central Precocious Puberty

Interventions

LeuprorelinDRUG

Leuprorelin will be administered every 4 weeks.

Eligibility

Sex: ALLMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

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

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)