Study of Lupron Depot In The Treatment of Central Precocious Puberty

Study Identifier
M90-516
CT.gov Identifier
NCT00660010
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Women's Health & Pregnancy - Other
    • Study Drug
  • Lupron (leuprolide acetate)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    N/A - 10 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys. - Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH > 10 U/L at baseline). - Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing. - Bone age advanced at least 1 year beyond the chronological age at entry into the study. - The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized. - No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.
    Exclusion Criteria:
    - Irradiation to the central nervous system. - Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

    Protocol Summary

    The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and

    effective in treating children with Central Precocious Puberty (CPP), and to assess long term

    effects of leuprolide acetate treatment after therapy is discontinued.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 46673
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 46671
    San Francisco, California, United States, 94122
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 14921
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 14343
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 14341
    St. Petersburg, Florida, United States, 33701
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 14342
    Indianapolis, Indiana, United States, 46202
    Status
    Not applicable
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