A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

Study Identifier
M16-904
CT.gov Identifier
NCT03695237
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Women's Health & Pregnancy - Other
    • Study Drug
  • Leuprolide Acetate (LA)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 11 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria: * Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age). * No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Pediatric Endocrinology Associates /ID# 200629
    Long Beach, California, United States, 90806-1651
    Status
    Not applicable
    Location
    Rady Children's Hospital San Diego /ID# 202491
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Children's Hospital Colorado /ID# 201645
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Pediatric Endocrine Associates /ID# 201089
    Greenwood Village, Colorado, United States, 80111
    Status
    Not applicable
    Location
    Nemours Children's Health System /ID# 201331
    Jacksonville, Florida, United States, 32207
    Status
    Not applicable
    Location
    Arnold Palmer Hospital /ID# 201624
    Orlando, Florida, United States, 32806
    Status
    Not applicable
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