A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
- Conditions
- Central Precocious Puberty (CPP)
- Interventions
- Registration Number
- NCT03695237
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Leuprolide Acetate (LA) Leuprolide Acetate (LA) Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.
- Primary Outcome Measures
Name Time Method 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 Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection. 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.
- Secondary Outcome Measures
Name Time Method Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL Weeks 72, 96, 120, and 144 Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed
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 Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 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 Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48).
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 Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used.
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144 Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system.
A ratio less than 1 indicates less advancement of bone age compared to chronological age.Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) Weeks 72, 96, 120, and 144 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.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. 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.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 Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics).
Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging.
Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging.Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL Weeks 72, 96, 120, and 144 Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.
Trial Locations
- Locations (18)
Rady Children's Hospital San Diego /ID# 202491
🇺🇸San Diego, California, 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
Children's Hospital Colorado /ID# 201645
🇺🇸Aurora, Colorado, United States
University of Minnesota /ID# 200508
🇺🇸Minneapolis, Minnesota, United States
Pediatric Endocrinology Associates /ID# 200629
🇺🇸Long Beach, California, United States
Pediatric Endocrine Associates /ID# 201089
🇺🇸Greenwood Village, Colorado, United States
Nemours Children's Health System /ID# 201331
🇺🇸Jacksonville, Florida, 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
Pediatric Endocrine Research Associates /ID# 200131
🇵🇷San Juan, Puerto Rico
Cook Children's Med. Center /ID# 212937
🇺🇸Fort Worth, Texas, United States
Multicare Institute for Research and Innovation /ID# 202188
🇺🇸Tacoma, Washington, United States
Arnold Palmer Hospital /ID# 201624
🇺🇸Orlando, Florida, United States
Children's Mercy Hospital/ID# 200221
🇺🇸Kansas City, Missouri, United States