A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
1 other identifier
interventional
45
2 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2018
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2021
CompletedResults Posted
Study results publicly available
May 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2023
CompletedMay 29, 2024
May 1, 2024
2.5 years
October 2, 2018
April 18, 2023
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Secondary Outcomes (9)
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Weeks 12, 20, 24, 44, and 48
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Weeks 12, 20, 24, 44, and 48
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144
- +4 more secondary outcomes
Study Arms (1)
Leuprolide Acetate (LA)
EXPERIMENTALParticipants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.
Interventions
Administered intramuscularly as an injection
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (18)
Pediatric Endocrinology Associates /ID# 200629
Long Beach, California, 90806-1651, United States
Rady Children's Hospital San Diego /ID# 202491
San Diego, California, 92123, United States
Children's Hospital Colorado /ID# 201645
Aurora, Colorado, 80045, United States
Pediatric Endocrine Associates /ID# 201089
Greenwood Village, Colorado, 80111, United States
Nemours Children's Health System /ID# 201331
Jacksonville, Florida, 32207, United States
Arnold Palmer Hospital /ID# 201624
Orlando, Florida, 32806, United States
Van Meter Pediatric Endocrinology /ID# 201688
Atlanta, Georgia, 30318-2508, United States
Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878
Idaho Falls, Idaho, 83404-7596, United States
Indiana University /ID# 200526
Indianapolis, Indiana, 46202, United States
Pediatric Endocrine Associates /ID# 202396
Boston, Massachusetts, 02114, United States
University of Minnesota /ID# 200508
Minneapolis, Minnesota, 55455-1450, United States
Children's Mercy Hospital/ID# 200221
Kansas City, Missouri, 64111, United States
University of Oklahoma /ID# 200659
Tulsa, Oklahoma, 74135-2527, United States
Penn State Hershey Medical Ctr /ID# 200287
Hershey, Pennsylvania, 17033-2360, United States
Children's Hospital of Philadelphia - Main /ID# 203846
Philadelphia, Pennsylvania, 19104-4319, United States
Cook Children's Med. Center /ID# 212937
Fort Worth, Texas, 76104, United States
Multicare Institute for Research and Innovation /ID# 202188
Tacoma, Washington, 98405, United States
Pediatric Endocrine Research Associates /ID# 200131
San Juan, 00935, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2018
First Posted
October 4, 2018
Study Start
October 24, 2018
Primary Completion
May 6, 2021
Study Completion
November 29, 2023
Last Updated
May 29, 2024
Results First Posted
May 16, 2023
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.