A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Puberty, Precocious
Intervention: Leuprolide acetate 11.25 mg (Drug); Leuprolide acetate 30 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Peter Bacher, MD,, Study Director, Affiliation: Abbott
Summary
The purpose of this study is to determine if 11. 25 and 30 mg formulations of leuprolide are
effective in treating children with Central Precocious Puberty (CPP).
Clinical Details
Official title: A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6
Secondary outcome: Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by VisitPercentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit Peak-stimulated Luteinizing Hormone Concentration by Visit Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6 Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6 Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6
Detailed description:
Study Design:
A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a
1: 1 ratio to receive 2 injections of either leuprolide acetate 11. 25 mg or 30 mg depot
formulation, each injection administered 3 mo apart (6 mo of treatment):
This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a
posttreatment follow-up period (12 weeks following the Mo 6 visit). Study visits will occur
at Screening, Day 1, Week 2 (only for subjects participating in the pharmacokinetic subset),
Mo 1, 2, 3, Mo 6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up
Visit.
This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject has a clinical diagnosis of CPP.
- Eligible to receive at least 6 mo of therapy to treat CPP after study entry.
- Bone age advanced at least 1 year beyond the chronological age at time of diagnosis
or first treatment.
- In general good health with no uncontrolled, clinically significant disease which
would interfere with bone maturation or mask the objectives of this protocol as
assessed by the investigator.
Additional criteria for subjects who have not had previous treatment:
- Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1.
- Has pretreatment pubertal response to leuprolide acetate stimulation (luteinizing
hormone ≥8 mIU/mL) at Screening.
- Breast pubertal staging of at least 2 in girls; testicular volume of at least 4 cc or
testicular length greater than 2. 5 cm in boys at Screening.
Additional criteria for subjects previously treated:
- Girls 2-10 years inclusive or boys 2-11 years inclusive at Day 1.
- Must have been on standard gonadotropin releasing hormone analog therapy for at least
the 6 mo prior to Day 1.
- Has documented maintenance of luteinizing hormone suppression as evidenced by peak
stimulated level <4 mIU/mL at Screening.
Exclusion Criteria:
- Incomplete precocious puberty (premature thelarche, premature adrenarche).
- Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal
hyperplasia, testotoxicosis in boys, human chorionic gonadotropin secreting tumor or
McCune-Albright syndrome in girls.
- Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal
function other than premature secretion of gonadotropins not adequately controlled.
- Unstable intracranial tumors (unresponsive to treatment/expanding) except hamartoma.
- Previous treatment with GnRHa therapy requiring leuprolide acetate for depot
suspension >15 mg monthly.
- Bone age >13 years for girls and >14 years for boys.
- Any other condition interfering with growth, ie, skeletal dysplasia, cerebral palsy.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic
steroid use, renal failure, moderate to severe scoliosis.
- Diagnosis of short stature, ie more than 2. 25 standard deviations below the mean
height for age (growth chart measurement).
- Prior or current therapy with medroxyprogesterone acetate or growth hormone.
- Has an abnormal laboratory value suggesting a clinically significant underlying
disease .
- Creatinine >1. 5 mg/dL, alanine aminotransferase and/or aspartate aminotransferase
>2. 0 x upper limit of normal, or total bilirubin >2. 0 mg/dL with aspartate
aminotransferase/alanine aminotransferase elevated above normal limits.
- Positive pregnancy test.
- Known hypersensitivity to study medication or its excipients.
- Participation in another drug research within 3 mo of enrollment into this study.
- Prior or current therapy with insulin-like growth factor-1.
- Use of an estrogen preparation within 2 mo prior to Day 1.
Locations and Contacts
Site Reference ID/Investigator# 17922, Bayamon 00960, Puerto Rico
Site Reference ID/Investigator# 17923, Ponce 00717-2116, Puerto Rico
Site Reference ID/Investigator# 18242, San Juan 00936-5067, Puerto Rico
Site Reference ID/Investigator# 19661, San Juan 00936-8344, Puerto Rico
Site Reference ID/Investigator# 8765, Birmingham, Alabama 35233, United States
Site Reference ID/Investigator# 11522, Long Beach, California 90806, United States
Site Reference ID/Investigator# 8756, Los Angeles, California 90027, United States
Site Reference ID/Investigator# 8755, San Diego, California 92123, United States
Site Reference ID/Investigator# 8761, San Diego, California 92123, United States
Site Reference ID/Investigator# 8772, Stanford, California 94305-5208, United States
Site Reference ID/Investigator# 8749, Greenwood Village, Colorado 80111, United States
Site Reference ID/Investigator# 8771, Gainesville, Florida 32608, United States
Site Reference ID/Investigator# 8764, Jacksonville, Florida 32207, United States
Site Reference ID/Investigator# 17621, Pensacola, Florida 32504, United States
Site Reference ID/Investigator# 8752, Indianapolis, Indiana 46202, United States
Site Reference ID/Investigator# 8766, Shreveport, Louisiana 71103, United States
Site Reference ID/Investigator# 8768, Minneapolis, Minnesota 55455, United States
Site Reference ID/Investigator# 17341, St. Paul, Minnesota 55102, United States
Site Reference ID/Investigator# 8759, Kansas City, Missouri 64108, United States
Site Reference ID/Investigator# 8750, Oklahoma City, Oklahoma 73104, United States
Site Reference ID/Investigator# 8760, Tulsa, Oklahoma 74135, United States
Site Reference ID/Investigator# 8763, Hershey, Pennsylvania 17033, United States
Site Reference ID/Investigator# 8754, Salt Lake City, Utah 84108, United States
Site Reference ID/Investigator# 8753, Seattle, Washington 98105, United States
Site Reference ID/Investigator# 8762, Seattle, Washington 98104, United States
Additional Information
Starting date: June 2008
Last updated: October 25, 2011
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