Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty

NCT06926933 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HLA24IV_1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP. Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.

Conditions

CPP

Outcome Measures

Primary Outcomes (1)

• The percentage (%) of subjects with serum LH concentrations < 4 IU/L following an GnRH stimulation test

  Blood samples for serum LH concentrations (as appropriate) will be collected at the appropriate assessment times and analyzed by a central laboratory.

  at week 24

Secondary Outcomes (5)

• The percentage (%) of subjects with suppressed serum LH concentrations (< 4 IU/L) 30-minutes post GnRH stimulation test

  at week 12, 48, 72, 96

• The percentage (%) of subjects with suppressed serum FSH (< 2.5 mIU/mL), estradiol (< 20 pg/mL, for girl) or testosterone (< 30 ng/dL, for boy)

  at week 12, 24, 48, 72, 96

• The percentage of subject of Tanner stage (including menstruation)

  at week 12, 24, 48, 72, 96

• Height velocity (growth rate)

  at week 12, 24, 48, 72, 96

• The ratio of bone age and chronological age

  at week 12, 24, 48, 72, 96

Study Arms (1)

Eligard® 45 mg

EXPERIMENTAL

SC injection of study drug (45 mg of leuprolide acetate for injectable suspensions)

Drug: Eligard® 45 mg

Interventions

Eligard® 45 mg DRUG

45 mg of leuprolide acetate

Eligard® 45 mg

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L
• A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older \~ under 9 years of age) Girl (4 years of age or older \~ under 8 years of age) Tanner Stage : Level 2 or higher
• Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
• Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
• Children with a body weight of more than 20 kg at screening
• Children have a bone age that is ≥1 year older than their chronological age at screening
• A signed written consent form by a legal representative who has been informed about this study

You may not qualify if:

• Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
• Prior or current GnRH treatment for CPP
• Non-progressing isolated premature thelarche
• Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
• Prior (within 12 weeks of Screening) use of medications
• Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)
• Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)
• Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)
• Herbal Medicines
• Prior or current therapy with growth hormone
• Major medical or psychiatric illness that could interfere with study visits
• Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)
• Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women
• Known hypersensitivity to GnRH or related compounds
• Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead

Study Sites (9)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Chosun University Hospital

Kwangju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital At Gangdong

Seoul, South Korea

RECRUITING

Ajou University Medical Center

Suwon, South Korea

RECRUITING

MeSH Terms

Interventions

luprolide acetate gel depot

Study Officials

• Eunhee Lee

  Hanall Biopharma

  STUDY DIRECTOR

Central Study Contacts

Sunmi Park

CONTACT

0222041763; parksm@hanall.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: December 12, 2024
• Primary Completion: April 20, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

KR (9)