A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
NCT ID: NCT03695237
Last Updated: 2024-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2018-10-24
2023-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Leuprolide Acetate (LA)
Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.
Leuprolide Acetate (LA)
Administered intramuscularly as an injection
Interventions
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Leuprolide Acetate (LA)
Administered intramuscularly as an injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
2 Years
11 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Pediatric Endocrinology Associates /ID# 200629
Long Beach, California, United States
Rady Children's Hospital San Diego /ID# 202491
San Diego, California, United States
Children's Hospital Colorado /ID# 201645
Aurora, Colorado, United States
Pediatric Endocrine Associates /ID# 201089
Greenwood Village, Colorado, United States
Nemours Children's Health System /ID# 201331
Jacksonville, Florida, United States
Arnold Palmer Hospital /ID# 201624
Orlando, Florida, United States
Van Meter Pediatric Endocrinology /ID# 201688
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878
Idaho Falls, Idaho, United States
Indiana University /ID# 200526
Indianapolis, Indiana, United States
Pediatric Endocrine Associates /ID# 202396
Boston, Massachusetts, United States
University of Minnesota /ID# 200508
Minneapolis, Minnesota, United States
Children's Mercy Hospital/ID# 200221
Kansas City, Missouri, United States
University of Oklahoma /ID# 200659
Tulsa, Oklahoma, United States
Penn State Hershey Medical Ctr /ID# 200287
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia - Main /ID# 203846
Philadelphia, Pennsylvania, United States
Cook Children's Med. Center /ID# 212937
Fort Worth, Texas, United States
Multicare Institute for Research and Innovation /ID# 202188
Tacoma, Washington, United States
Pediatric Endocrine Research Associates /ID# 200131
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M16-904
Identifier Type: -
Identifier Source: org_study_id
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