Status:
COMPLETED
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Precocious
Leuprolide Acetate
Eligibility:
All Genders
Phase:
PHASE3
Brief 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).
Detailed Description
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). Participants will receive a total of twelv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00667446
Start Date
December 1 2008
End Date
January 1 2013
Last Update
January 9 2014
Active Locations (20)
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1
Site Reference ID/Investigator# 13521
Birmingham, Alabama, United States, 35233
2
Site Reference ID/Investigator# 14922
Long Beach, California, United States, 90806
3
Site Reference ID/Investigator# 26043
Los Angeles, California, United States, 90027
4
Site Reference ID/Investigator# 20802
San Diego, California, United States, 92123