Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07710430

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Central Precocious Puberty Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

leuprorelin

Drug

Leuprorelin will be administered every 4 weeks.

Primary outcomes

  1. 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

  1. Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk

    Time frame: 48 weeks and 96 weeks after treatment initiation

  2. 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

  3. Changes from baseline in pubertal development: Tanner stage

    Time frame: Up to 96 weeks after treatment initiation

  4. Changes from baseline in growth related parameters: height in centimeter

    Time frame: Up to 96 weeks after treatment initiation

  5. Changes from baseline in growth related parameters: weight in kilograms

    Time frame: Up to 96 weeks after treatment initiation

  6. Safety: Number of participants with treatment-related adverse events as assessed by the investigator

    Time frame: Up to 96 weeks after treatment initiation

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Lead

CONTACT

[email protected]

02-6987-4151

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 17, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.