Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this extension 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), 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.