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”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Study Primary Completion Date: November 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Leuprolide acetate 11.25 mg
  • Four intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
• Drug: Leuprolide acetate 30 mg
  • Four intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Suppression of luteinizing hormone concentrations (<4 mIU/mL).
  • Time Frame: Months 6 and 12
    Safety Issue?: Yes

Secondary Measures

• Suppression of sex steroids (estradiol <20 pg/mL in girls and testosterone <30 ng/dL in boys).
  • Time Frame: Months 6 and 12
    Safety Issue?: Yes
• Peak stimulated luteinizing hormone concentrations.
  • Time Frame: Months 6 and 12
    Safety Issue?: Yes
• Suppression of the physical signs of puberty.
  • Time Frame: Months 6 and 12
    Safety Issue?: Yes
• 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.
  • Time Frame: Months 6 and 12
    Safety Issue?: Yes
• 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.
  • Time Frame: Month 12
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Overall Contact: Abbott Global Medical Services 800-633-9110 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667446

Study ID Number: L-CP07-177

ClinicalTrials.gov Identifier: NCT00667446

Health Authority: United States: Food and Drug Administration