Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, open-label, prospective study to evaluate the safety and efficacy of
      leuprorelin acetate DPS (Leuplin DPS) treatment quarterly in patients with central precocious
      puberty
    

Detailed description: 
      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.

             1. Female children aged '≥ 4 years ~ < 9 years (8 years plus 364 days)

             2. Those who fall under Tanner stage 2 at least (on condition that they started to
                have breast budding under the age of 8)

             3. Female children who showed pubertal LH response to GnRH stimulation test (peak ≥
                7mIU/mL)

             4. Those whose bone age increased by one year or more compared to their chronological
                age

             5. Subjects and their guardians who gave written consent to participate in this study

        -  Exclusion Criteria.

             1. Those whose bone age is 11 years and 6 months or older

             2. Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner

             3. Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative

             4. Those who have received GnRH analog treatment

             5. Those who require treatment likely to influence the hypothalamic-pituitary-gonadal
                axis during the study period

             6. Those receiving growth hormone

             7. Those who are suspected of or diagnosed with malignant tumor

             8. Patients with severe renal failure or hepatic failure, whose participation in this
                study is impossible in the investigator's opinion

             9. 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

            10. Those who have participated in another clinical study within 90 days from the date
                when the IP was administered

            11. Those who are found to be ineligible for this study in the investigator's opinion
    

Intervention name(s): Leuplin DPS 11.25mg
Intervention type(s): Drug
Intervention description(s): Leuplin DPS 11.25mg s.c. every 12 weeks
Other intervention name(s): injection
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Intervention model description: Leuprorelin treatment
Masking: None (Open Label)
Primary purpose: Treatment