Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty

Official Title: “A 36 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 (36 months).

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 36 month open-label extension study.

This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit).

Subjects will receive a total of twelve (12) 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 will be administered 3 months apart for up to 36 months of treatment.

Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Leuprolide acetate 11.25 mg
• Experimental: Leuprolide acetate 30 mg

Primary Measures

• Suppression of peak-stimulated luteinizing hormone concentrations (< 4 mIU/mL).
  • Time Frame: Day 1, Months 6, 12, 24, and 36
    Safety Issue?: Yes

Secondary Measures

• Suppression of sex steroids (estradiol < 20 pg/mL in girls and testosterone < 30 ng/dL in boys).
  • Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
    Safety Issue?: Yes
• Peak stimulated luteinizing hormone concentrations.
  • Time Frame: Day 1, Months 6, 12, 24, and 36
    Safety Issue?: Yes
• Suppression of the physical signs of puberty.
  • Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
    Safety Issue?: Yes
• Change from baseline (from the lead-in study) in growth rate.
  • Time Frame: Day 1, Months 6, 12, 18, 24, 30, and 36
    Safety Issue?: Yes
• The ratio of change from baseline (from the lead-in study) in bone age/change from baseline in chronological age.
  • Time Frame: Day 1, Months 12, 24, and 36
    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, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
• 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 Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Peter Bacher, MD Study Director Abbott  

Information obtained from ClinicalTrials.gov on February 12, 2012

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