NCT06025409

Evaluate the Efficacy and Safety of DWJ108J

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.

Detailed description

The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Leuprolide Acetate 11.25 MG/ML	Subcutaneous injection

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-02-28
• Completion: 2025-08-31
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: South Korea