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

AbbVie45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Central Precocious Puberty (CPP)

Interventions

Leuprolide Acetate (LA)DRUG

Administered intramuscularly as an injection

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (18)

Pediatric Endocrinology Associates /ID# 200629

Long Beach, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Time frame: 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

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).

Time frame: 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

Data from ClinicalTrials.gov

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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

...and 8 more locations

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).

Time frame: Weeks 12, 20, 24, 44, and 48

Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty

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.

Time frame: 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

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.

Time frame: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144

Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age

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.

Time frame: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144

Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)

Time frame: Weeks 72, 96, 120, and 144

Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL

Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.

Time frame: Weeks 72, 96, 120, and 144

Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL

Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed

Time frame: Weeks 72, 96, 120, and 144