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

NCT ID: NCT00667446

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-01-31

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 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuprolide Acetate 3M Depot 11.25 mg

Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart.

Group Type: EXPERIMENTAL

Leuprolide Acetate 3 Month Depot

Intervention Type: DRUG

Leuprolide Acetate 3M Depot 30 mg

Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.

Group Type: EXPERIMENTAL

Leuprolide Acetate 3 Month Depot

Intervention Type: DRUG

Interventions

Leuprolide Acetate 3 Month Depot

Intervention Type: DRUG

Other Intervention Names

ABT-818; Lupron; Leuprorelin acetate

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Bacher, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Countries

United States; Puerto Rico

References

Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13.

Reference Type: DERIVED

PMID: 24926950 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

L-CP07-177

Identifier Type: -

Identifier Source: org_study_id