Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty
Information source: Abbott
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Abbott Overall contact:
Abbott Global Medical Services, Phone: 800-633-9110
Summary
The purpose of this study is to determine if leuprolide acetate (11. 25 mg and 30 mg) is safe
in treating children with Central Precocious Puberty over a longer period of time (12
months).
Clinical Details
Official title: A 12 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Primary outcome: Suppression of luteinizing hormone concentrations (<4 mIU/mL).
Secondary outcome: Suppression of sex steroids (estradiol <20 pg/mL in girls and testosterone <30 ng/dL in boys).Peak stimulated luteinizing hormone concentrations. Suppression of the physical signs of puberty. Change from baseline (from the lead-in study) in growth rate within each of the subgroups of children not previously treated and and previously treated. The ratio of change from baseline (form the lead-in study) in bone age/change from baseline in chronological age within each of the subgroups of children not previously treated and previously treated.
Detailed description:
Approximately 70 subjects with Central Precocious Puberty from approximately 25 sites who
completed the treatment period of the lead-in study, L-CP07-167, will enter this 12 month
open-label extension study.
Subjects will receive a total of four (4) injections of the same treatment they received in
the lead-in study, either leuprolide acetate 11. 25 mg or 30 mg depot formulation, each
injection administered 3 months apart.
This study includes a 12-month treatment period (four 3-month treatment cycles), and a
posttreatment follow-up period (12 weeks following the Month 12 visit). Study visits will
occur at Day 1, Months 3, 6, 9 and 12, and 12 weeks later, for the Posttreatment Follow-up
Visit.
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject completed the Treatment Period of the lead-in study, L-CP07-167, and has
documented luteinizing hormone suppression as evidenced by peak-stimulated
luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
- Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in
study.
- Subject is expected to receive at least 12 months of therapy to treat Central
Precocious Puberty after study entry.
- 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.
Exclusion Criteria:
- Incomplete precocious puberty (premature thelarche, premature adrenarche).
- Bone age >/=14 years for girls and >/=15 years for boys (based on the Month 6 lead in
study, L-CP07-167, radiographic results
- Has an abnormal laboratory value suggesting a clinically significant underlying
disease or condition.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic
steroid use, renal failure, moderate to severe scoliosis.
- Current therapy with medroxyprogesterone acetate.
- Current therapy with growth hormone.
- Current therapy with insulin-like growth factor-1 (IGF-1).
- Current use of an estrogen preparation.
- Any concomitant medical condition that, in the opinion of the investigator, may
expose a subject to an unacceptable level of safety risk or that affects subject
compliance.
- Subject has a positive pregnancy test.
Locations and Contacts
Abbott Global Medical Services, Phone: 800-633-9110
Birmingham, Alabama 35233, United States; Recruiting
San Diego, California 92123, United States; Recruiting
Greenwood Village, Colorado 80111, United States; Recruiting
Jacksonville, Florida 32207, United States; Recruiting
Shreveport, Louisiana 71130, United States; Recruiting
Minneapolis, Minnesota 55455, United States; Recruiting
Kansas City, Missouri 64108, United States; Recruiting
Tulsa, Oklahoma 74135, United States; Recruiting
Oklahoma CIty, Oklahoma 73104, United States; Recruiting
Hershey, Pennsylvania 17033, United States; Recruiting
Seattle, Washington 98104, United States; Recruiting
Additional Information
Starting date: December 2008
Last updated: September 29, 2009
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