Evaluate the Efficacy and Safety of DWJ108J
Central Precocious Puberty
About this trial
This is an interventional treatment trial for Central Precocious Puberty
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Ajou University medical centerRecruiting
Arms of the Study
Arm 1
Experimental
Experimental: Leuprorelin
Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.