Status:
UNKNOWN
Evaluate the Efficacy and Safety of DWJ108J
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Central Precocious Puberty
Eligibility:
All Genders
4-10 years
Phase:
PHASE3
Brief 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 l...
Eligibility Criteria
Inclusion
- Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
- Diagnosis of central precocious puberty
- For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
- In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent
Exclusion
- Following conditions at Visit 1(Screening) :
- Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
- requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
- Prior treatment with GnRH analogues
- Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
- Prior or current therapy with growth hormone
- has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine
- Meets the following criteria based on screening test results:
- AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06025409
Start Date
August 1 2023
End Date
August 31 2025
Last Update
September 6 2023
Active Locations (1)
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1
Ajou University medical center
Gyeonggi-do, South Korea