Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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
Intervention: Leuprolide Acetate 3 Month Depot (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s):
Peter Bacher, MD, Study Director, Affiliation: AbbVie
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).
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Secondary outcome: Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) Percentage of Male Participants With Suppression of Basal Testosterone Mean Peak-stimulated Luteinizing Hormone Concentration by Visit Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) Change From Baseline in Growth Rate Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
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 twelve injections of the same treatment they received in the lead-in study,
L-CP07-167 (NCT00635817) 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Site Reference ID/Investigator# 23182, Bayamon 00960, Puerto Rico
Site Reference ID/Investigator# 21721, Ponce 00717-2116, Puerto Rico
Site Reference ID/Investigator# 25908, Rio Piedras 00935, Puerto Rico
Site Reference ID/Investigator# 23082, San Juan 00936-8344, Puerto Rico
Site Reference ID/Investigator# 13521, Birmingham, Alabama 35233, United States
Site Reference ID/Investigator# 14922, Long Beach, California 90806, United States
Site Reference ID/Investigator# 26043, Los Angeles, California 90027, United States
Site Reference ID/Investigator# 20802, San Diego, California 92123, United States
Site Reference ID/Investigator# 22425, Greenwood Village, Colorado 80111, United States
Site Reference ID/Investigator# 18181, Jacksonville, Florida 32207, United States
Site Reference ID/Investigator# 26364, Pensacola, Florida 32504, United States
Site Reference ID/Investigator# 26983, Indianapolis, Indiana 46202, United States
Site Reference ID/Investigator# 20821, Shreveport, Louisiana 71130-3932, United States
Site Reference ID/Investigator# 23643, Minneapolis, Minnesota 55455, United States
Site Reference ID/Investigator# 23502, St. Paul, Minnesota 55102, United States
Site Reference ID/Investigator# 14121, Kansas City, Missouri 64108, United States
Site Reference ID/Investigator# 23802, Oklahoma City, Oklahoma 73104, United States
Site Reference ID/Investigator# 13324, Tulsa, Oklahoma 74135, United States
Site Reference ID/Investigator# 16506, Hershey, Pennsylvania 17033, United States
Site Reference ID/Investigator# 14024, Seattle, Washington 98104, United States
Additional Information
Starting date: December 2008
Last updated: January 8, 2014
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