Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty

Type and design of study (eg, parallel, crossover, double-blind, open, superiority, noninferiority).Blinding measures taken to minimize bias (eg, "single-blind; subjects receive blinded study medication").

A single arm, multicenter, open-label, prospective study. Requirements for run-in or washout of medication. Those who have been administered one of the following drugs within 2 weeks before they start to participate in this study

• Estrogens
• Antiestrogens
• Progesterones
• Steroids
• Oriental medicines

Description of population to be studied (eg, adults with chronic heart failure and ejection fraction below 40% or subjects with uncontrolled, long-term type 2 diabetes).

Children with central precocious puberty

• Inclusion Criteria.

• Female children aged '≥ 4 years ~ < 9 years (8 years plus 364 days)
• Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
• Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
• Those whose bone age increased by one year or more compared to their chronological age
• Subjects and their guardians who gave written consent to participate in this study
• Exclusion Criteria.

• Those whose bone age is 11 years and 6 months or older
• Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
• Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
• Those who have received GnRH analog treatment
• Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
• Those receiving growth hormone
• Those who are suspected of or diagnosed with malignant tumor
• Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion
• Those who have been administered one of the following drugs within 2 weeks before they started to participate in this study, or who are expected to be administered during the study period

• Estrogens
• Antiestrogens
• Progesterones
• Steroids
• Oriental medicines
• Those who have participated in another clinical study within 90 days from the date when the IP was administered
• Those who are found to be ineligible for this study in the investigator's opinion

Inclusion criteria

• Female children aged '≥ 4 years ~ < 9 years (8 years plus 364 days)
• Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
• Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
• Those whose bone age increased by one year or more compared to their chronological age
• Subjects and their guardians who gave written consent to participate in this study

Exclusion criteria

• Those whose bone age is 11 years and 6 months or older
• Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
• Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
• Those who have received GnRH analog treatment
• Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
• Those receiving growth hormone
• Those who are suspected of or diagnosed with malignant tumor
• Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion
• Those who have been administered one of the following drugs within 2 weeks before they started to participate in this study, or who are expected to be administered during the study period

• Estrogens
• Antiestrogens
• Progesterones
• Steroids
• Oriental medicines
• Those who have participated in another clinical study within 90 days from the date when the IP was administered
• Those who are found to be ineligible for this study in the investigator's opinion