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

Completed · Phase 3

Conditions studied: Central Precocious Puberty (CPP)

In brief

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.

Key facts

Study ID

NCT03695237

Run by

AbbVie

People needed

45

Starts

2018-10-24

Expected to finish

2023-11-29

Last updated by the study team

2024-05-29

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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