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

NCT06926933 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-15

No results posted yet for this study

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

Interventions

DRUG

Eligard® 45 mg

45 mg of leuprolide acetate

Sponsors & Collaborators

  • HanAll BioPharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Eunhee Lee · Hanall Biopharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-04-20
Completion
2027-10-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926933 on ClinicalTrials.gov