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

Last updated: May 1, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Leuprolide Acetate (LA)

Clinical Study ID

NCT03695237
M16-904
  • Ages 2-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Leuprolide Acetate (LA)
Phase: 3
Study Start date:
October 24, 2018
Estimated Completion Date:
November 29, 2023

Connect with a study center

  • Pediatric Endocrine Research Associates /ID# 200131

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Puerto Rico Medical Research Center /ID# 213054

    Hato Rey, 00917
    Puerto Rico

    Site Not Available

  • Pediatric Endocrine Research Associates /ID# 200131

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Pediatric Endocrinology Associates /ID# 200629

    Long Beach, California 90806-1651
    United States

    Site Not Available

  • Rady Children's Hospital San Diego /ID# 202491

    San Diego, California 92123
    United States

    Site Not Available

  • Children's Hospital Colorado /ID# 201645

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Pediatric Endocrine Associates /ID# 201089

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Nemours Children's Health System /ID# 201331

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Arnold Palmer Hospital /ID# 201624

    Orlando, Florida 32806
    United States

    Site Not Available

  • Shriner's Hospital for Children - Tampa /ID# 207745

    Tampa, Florida 33612-9411
    United States

    Site Not Available

  • Van Meter Pediatric Endocrinology /ID# 201688

    Atlanta, Georgia 30318-2508
    United States

    Site Not Available

  • Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878

    Idaho Falls, Idaho 83404-7596
    United States

    Site Not Available

  • Indiana University /ID# 200526

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Pediatric Endocrine Associates /ID# 202396

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • UMass Chan Medical School /ID# 203327

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Minnesota /ID# 200508

    Minneapolis, Minnesota 55455-1450
    United States

    Site Not Available

  • Children's Hospitals and Clinics of MN /ID# 208992

    Saint Paul, Minnesota 55102-2346
    United States

    Site Not Available

  • Children's Mercy Hospital and Clinics /ID# 200221

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Children's Mercy Hospital/ID# 200221

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • UBMD - Pediatrics /ID# 201978

    Buffalo, New York 14203
    United States

    Site Not Available

  • The Mount Sinai Hospital /ID# 200675

    New York, New York 10029
    United States

    Site Not Available

  • Cincinnati Children's Hospital /ID# 202185

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Oklahoma /ID# 200659

    Tulsa, Oklahoma 74135-2527
    United States

    Site Not Available

  • Penn State Children's Hospital /ID# 200287

    Hershey, Pennsylvania 17033-2360
    United States

    Site Not Available

  • Penn State Hershey Medical Ctr /ID# 200287

    Hershey, Pennsylvania 17033-2360
    United States

    Site Not Available

  • Children's Hospital of Philadelphia - Main /ID# 203846

    Philadelphia, Pennsylvania 19104-4319
    United States

    Site Not Available

  • Cook Children's Med. Center /ID# 212937

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • MultiCare Institute Health System /ID# 202188

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Multicare Institute for Research and Innovation /ID# 202188

    Tacoma, Washington 98405
    United States

    Site Not Available

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