A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

• Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 mlU/mL)[ Time Frame: Up to Week 48 ]
  It is measured by peak LH stimulation test
• Percentage of female participants with suppression of basal estradiol to <20 pg/mL[ Time Frame: Up to Week 48 ]
  Female participants with suppression of basal estradiol to < 20 pg/mL are assessed
• Percentage of male participants with suppression of testosterone to <30 ng/dL[ Time Frame: Up to Week 48 ]
  Male participants with suppression of testosterone to < 30 ng/dL are assessed
• Percentage of participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL)[ Time Frame: Up to Week 144 ]
  Participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) are assessed
• Percentage of female participants with maintenance of suppression of basal estradiol to <20 pg/mL[ Time Frame: Up to Week 144 ]
  Female participants with maintenance of suppression of basal estradiol to < 20 pg/mL are assessed
• Percentage of male participants with maintenance of suppression of testosterone to <30 ng/dL[ Time Frame: Up to Week 144 ]
  Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed
• Percentage of participants with suppression of the physical signs of puberty[ Time Frame: Up to Week 144 ]
  Breast development in females, testicular volume or genital development in males will be assessed using modified Tanner staging.
• Incremental growth rate[ Time Frame: Up to Week 144 ]
  Incremental growth rate (cm/year) will be assessed.
• Ratio of change from baseline in bone age vs chronological age[ Time Frame: Up to Week 144 ]
  Ratio of change from baseline in bone age vs chronological age is assessed

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

• Drug: Leuprolide Acetate (LA)
  It is administered intramuscularly as an injection

• Experimental: Participants receiving Leuprolide Acetate (LA)
  Participants with Central Precocious Puberty receiving LA