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Evaluate the Efficacy and Safety of DWJ108J

Central Precocious Puberty Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06025409
Study type Interventional
Source Daewoong Pharmaceutical Co. LTD.
Contact Yeonseo Choi, MD. PhD
Phone 82-2-550-8800
Email yeonseo@daewoong.co.kr
Status Recruiting
Phase Phase 3
Start date August 1, 2023
Completion date August 31, 2025
View Details
See also
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Completed NCT00779103 - Histrelin Subcutaneous Implant in Children With Central Precocious Puberty Phase 3
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Completed NCT04736602 - Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. Phase 3
Recruiting NCT05341115 - A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty Phase 4
Completed NCT02993926 - A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
Recruiting NCT02811471 - Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty Phase 3
Completed NCT03316482 - Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty Phase 4
Recruiting NCT06129539 - A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty Phase 3
Completed NCT01634321 - The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty Phase 4
Terminated NCT02006680 - Markers of Pubertal Suppression During Therapy for Precocious Puberty
Completed NCT01278290 - Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls Phase 3
Completed NCT02427958 - A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants Phase 4
Completed NCT05029622 - A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. Phase 3
Completed NCT01467882 - Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Phase 3
Recruiting NCT00438217 - Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children Phase 4