A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
NCT ID: NCT00635817
Last Updated: 2011-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2008-06-30
2010-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Leuprolide acetate 11.25 mg
There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B.
Leuprolide acetate 11.25 mg
Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
Leuprolide acetate 30 mg
There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D.
Leuprolide acetate 30 mg
Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
Interventions
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Leuprolide acetate 11.25 mg
Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
Leuprolide acetate 30 mg
Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
11 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Bacher, MD,
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 8765
Birmingham, Alabama, United States
Site Reference ID/Investigator# 11522
Long Beach, California, United States
Site Reference ID/Investigator# 8756
Los Angeles, California, United States
Site Reference ID/Investigator# 8755
San Diego, California, United States
Site Reference ID/Investigator# 8761
San Diego, California, United States
Site Reference ID/Investigator# 8772
Stanford, California, United States
Site Reference ID/Investigator# 8749
Greenwood Village, Colorado, United States
Site Reference ID/Investigator# 8771
Gainesville, Florida, United States
Site Reference ID/Investigator# 8764
Jacksonville, Florida, United States
Site Reference ID/Investigator# 17621
Pensacola, Florida, United States
Site Reference ID/Investigator# 8752
Indianapolis, Indiana, United States
Site Reference ID/Investigator# 8766
Shreveport, Louisiana, United States
Site Reference ID/Investigator# 8768
Minneapolis, Minnesota, United States
Site Reference ID/Investigator# 17341
Saint Paul, Minnesota, United States
Site Reference ID/Investigator# 8759
Kansas City, Missouri, United States
Site Reference ID/Investigator# 8750
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 8760
Tulsa, Oklahoma, United States
Site Reference ID/Investigator# 8763
Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 8754
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 8762
Seattle, Washington, United States
Site Reference ID/Investigator# 8753
Seattle, Washington, United States
Site Reference ID/Investigator# 17922
Bayamón, , Puerto Rico
Site Reference ID/Investigator# 17923
Ponce, , Puerto Rico
Site Reference ID/Investigator# 18242
San Juan, , Puerto Rico
Site Reference ID/Investigator# 19661
San Juan, , Puerto Rico
Countries
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References
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Lee PA, Klein K, Mauras N, Neely EK, Bloch CA, Larsen L, Mattia-Goldberg C, Chwalisz K. Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty. J Clin Endocrinol Metab. 2012 May;97(5):1572-80. doi: 10.1210/jc.2011-2704. Epub 2012 Feb 16.
Other Identifiers
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L-CP07-167
Identifier Type: -
Identifier Source: org_study_id