Clinical trial NCT03695237: A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Precocious Puberty (CPP)
Keywords: Central Precocious Puberty (CPP)
Leuprolide Acetate (LA)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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.
measure: Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
timeFrame: Weeks 12, 20, 24, 44, and 48
measure: Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
timeFrame: Weeks 12, 20, 24, 44, and 48
measure: Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
timeFrame: Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
measure: Parts 1 and 2: Change From Baseline in Incremental Growth Rate
timeFrame: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144
measure: Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
timeFrame: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144
measure: Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
timeFrame: Weeks 72, 96, 120, and 144
measure: Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
timeFrame: Weeks 72, 96, 120, and 144
measure: Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
timeFrame: Weeks 72, 96, 120, and 144
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Pediatric Endocrinology Associates /ID# 200629
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego /ID# 202491
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado /ID# 201645
state: Colorado
city: Greenwood Village
country: United States
facility: Pediatric Endocrine Associates /ID# 201089
state: Colorado
city: Jacksonville
country: United States
facility: Nemours Children's Health System /ID# 201331
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital /ID# 201624
state: Florida
city: Atlanta
country: United States
facility: Van Meter Pediatric Endocrinology /ID# 201688
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878
state: Idaho
city: Indianapolis
country: United States
facility: Indiana University /ID# 200526
state: Indiana
city: Boston
country: United States
facility: Pediatric Endocrine Associates /ID# 202396
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota /ID# 200508
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital/ID# 200221
state: Missouri
city: Tulsa
country: United States
facility: University of Oklahoma /ID# 200659
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Medical Ctr /ID# 200287
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 203846
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Children's Med. Center /ID# 212937
state: Texas
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation /ID# 202188
state: Washington
city: San Juan
country: Puerto Rico
facility: Pediatric Endocrine Research Associates /ID# 200131
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: