A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Leuprorelin
Intervention description: Suspension for injection.
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 307.0
Sex: All
Minimum age: 1 Year
Maximum age: 9 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the
      treatment of Central Precocious Puberty (CPP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant and/or parent(s) or legal guardian
             are capable of understanding and complying with protocol requirements.

          2. The participant or the participant's parent(s) or legally acceptable representative
             signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures.

          3. Has onset of appearance of secondary sexual characteristic earlier than age 8.0 years
             in girls or earlier than 9.0 years in boys and the symptom is persistent, and has
             confirmed diagnosis of CPP.

          4. Has basal luteinizing hormone (LH) level greater than (>) 5.0 international units per
             liter (IU/L) or peak LH >3.3 IU/L with LH/follicle-stimulating factor (FSH) >0.6 in
             stimulation test.

          5. Has evidence of gonadal development evaluated by ultrasonography: ovarian volume >=1
             milliliter (mL) with multiple follicles >=4 millimeter (mm) in any ovary or uterine
             enlargement in females or testicular volume >=4 mL in males.

          6. Has advanced bone age (BA) >=1 year and BA is less than or equal to (<=) 11.5 years in
             females or <=12.5 years in males OR predicted adult height <150 centimeter (cm) in
             females or <160 cm in males OR standard deviation score (SDS) <-2 standard deviations
             (SD) OR rapid growth defined as growth of BA /growth of chronologic age >1. BA is
             determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards at
             screening.

          7. Has anticipated treatment duration of at least 2 year in investigator's judgment.

          8. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 90 days after last dose.

          9. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent throughout the duration of the study.

         10. The female participant who, at the discretion of the investigator, is deemed to be of
             child bearing potential must provide negative urine pregnancy text at Day -1 or Day 1
             prior to drug administration.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to Screening.

          2. Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous
             clinical study or as a therapeutic agent.

          3. Is an immediate family member, study site employee, or is in a dependent relationship
             with a study site employee who is involved in the conduct of this study (example [eg],
             spouse, parent, child, sibling) or may consent under duress.

          4. Has any findings in his/her medical history, physical examination, or safety clinical
             laboratory tests giving reasonable suspicion of underlying disease that might
             interfere with the conduct of the trial.

          5. Has any concomitant medical condition that, in the opinion of the investigator, may
             expose a participant to an unacceptable level of safety risk or that affects
             participant compliance.

          6. Has any screening abnormal laboratory value that suggests a clinically significant
             underlying disease or condition that may prevent the participant from entering the
             study; or the participant has: creatinine >=1.5 milligram per deciliter (mg/dL),
             alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the
             upper limit of normal (ULN), or total bilirubin >2.0 mg/dL, with AST/ALT elevated
             above the limits of normal values.

          7. Has a history or clinical manifestations of significant adrenal or thyroid diseases or
             intracranial tumor OR has a history of malignant disease.

          8. Has a history of hypersensitivity or allergies to leuprorelin, or related compounds
             including any excipients of the compound.

          9. Has a diagnosis of peripheral precocious puberty.

         10. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening Visit.

         11. Participant or parent(s), at the discretion of the investigator, is unlikely to comply
             with the protocol or is unsuitable for any of other reason.

         12. If female, the participant is of childbearing potential (eg, not sterilized).

         13. If female, the participant is pregnant or lactating or intending to become pregnant
             before, during, or within 1 month after participating in this study; or intending to
             donate ova during such time period.

         14. If male, the participant intends to donate sperm during the course of this study or
             for 90 days thereafter.

         15. Has participated in another clinical study and/or has received any investigational
             compound within 30 days prior to Screening.