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

Completed · Phase 3

Conditions studied: Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging, Depot Formulation, Suppression of LH, Central Precocious Puberty (CPP), Gonadotrophin-releasing Hormone (GnRH), Lupron, GnRH Analog, Pediatrics Central Precocious Puberty

In brief

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).

Key facts

Study ID

NCT00667446

Run by

AbbVie (prior sponsor, Abbott)

People needed

72

Starts

2008-12-01

Expected to finish

2013-01-01

Last updated by the study team

2014-01-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 13521 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 14922 — Long Beach, California, United States
• Site Reference ID/Investigator# 26043 — Los Angeles, California, United States
• Site Reference ID/Investigator# 20802 — San Diego, California, United States
• Site Reference ID/Investigator# 22425 — Greenwood Village, Colorado, United States
• Site Reference ID/Investigator# 18181 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 26364 — Pensacola, Florida, United States
• Site Reference ID/Investigator# 26983 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 20821 — Shreveport, Louisiana, United States
• Site Reference ID/Investigator# 23643 — Minneapolis, Minnesota, United States
• Site Reference ID/Investigator# 23502 — Saint Paul, Minnesota, United States
• Site Reference ID/Investigator# 14121 — Kansas City, Missouri, United States
• Site Reference ID/Investigator# 23802 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 13324 — Tulsa, Oklahoma, United States
• Site Reference ID/Investigator# 16506 — Hershey, Pennsylvania, United States
• Site Reference ID/Investigator# 14024 — Seattle, Washington, United States
• Site Reference ID/Investigator# 23182 — Bayamón, Puerto Rico
• Site Reference ID/Investigator# 21721 — Ponce, Puerto Rico
• Site Reference ID/Investigator# 25908 — Rio Piedras, Puerto Rico
• Site Reference ID/Investigator# 23082 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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