Overview

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

Eligibility

Inclusion Criteria:

1. Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
2. Diagnosis of central precocious puberty
3. 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
4. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
5. In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent

Exclusion Criteria:

1. 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

2. requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
3. Prior treatment with GnRH analogues
4. Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
5. Prior or current therapy with growth hormone
6. 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
7. 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

8. 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