This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
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 look at whether leuprorelin can stop early Central Precocious Puberty.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Subcutaneous injection
Ajou University medical center
Gyeonggi-do, South Korea
RECRUITINGPercentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Time frame: 6 months
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
Time frame: 3 months
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
Time frame: Baseline, 3 and 6 months
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
Time frame: 3 and 6 months
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
Time frame: Baseline, 3 and 6 months
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
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Time frame: 6 months
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
Time frame: 6 months
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
Time frame: 6 months