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

NCT00667446 | Completed Phase 3 Results

• 1 other identifier: L-CP07-177
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 20

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).

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

Keywords

GnRH analog; Luteinizing hormone (LH); Gonadotrophin-releasing hormone agonist(GnRHa); Suppression of LH; Gonadotrophin-releasing hormone (GnRH); CPP; Leuprolide acetate; Central Precocious Puberty; Depot formulation; Lupron; Tanner staging; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone

  Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.

  Day 1, Months 6, 12, 24, and 36

Secondary Outcomes (8)

• Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)

  Day 1, Months 3, 6, 9, 12, and 24

• Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)

  Months 6, 9, 12, 24, 30, and 36

• Percentage of Male Participants With Suppression of Basal Testosterone

  Day 1, Months 3, 6, 9, 12, 24, 30, and 36

• Mean Peak-stimulated Luteinizing Hormone Concentration by Visit

  Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36

• Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)

  Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

Study Arms (2)

Leuprolide Acetate 3M Depot 11.25 mg

EXPERIMENTAL

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

Drug: Leuprolide Acetate 3 Month Depot

Leuprolide Acetate 3M Depot 30 mg

EXPERIMENTAL

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

Drug: Leuprolide Acetate 3 Month Depot

Interventions

Leuprolide Acetate 3 Month Depot DRUG

Also known as: ABT-818, Lupron, Leuprorelin acetate

Leuprolide Acetate 3M Depot 11.25 mg; Leuprolide Acetate 3M Depot 30 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (20)

Site Reference ID/Investigator# 13521

Birmingham, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 14922

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 26043

Los Angeles, California, 90027, United States

Location

Site Reference ID/Investigator# 20802

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 22425

Greenwood Village, Colorado, 80111, United States

Location

Site Reference ID/Investigator# 18181

Jacksonville, Florida, 32207, United States

Location

Site Reference ID/Investigator# 26364

Pensacola, Florida, 32504, United States

Location

Site Reference ID/Investigator# 26983

Indianapolis, Indiana, 46202, United States

Location

Site Reference ID/Investigator# 20821

Shreveport, Louisiana, 71130-3932, United States

Location

Site Reference ID/Investigator# 23643

Minneapolis, Minnesota, 55455, United States

Location

Site Reference ID/Investigator# 23502

Saint Paul, Minnesota, 55102, United States

Location

Site Reference ID/Investigator# 14121

Kansas City, Missouri, 64108, United States

Location

Site Reference ID/Investigator# 23802

Oklahoma City, Oklahoma, 73104, United States

Location

Site Reference ID/Investigator# 13324

Tulsa, Oklahoma, 74135, United States

Location

Site Reference ID/Investigator# 16506

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 14024

Seattle, Washington, 98104, United States

Location

Site Reference ID/Investigator# 23182

Bayamón, 00960, Puerto Rico

Location

Site Reference ID/Investigator# 21721

Ponce, 00717-2116, Puerto Rico

Location

Site Reference ID/Investigator# 25908

Rio Piedras, 00935, Puerto Rico

Location

Site Reference ID/Investigator# 23082

San Juan, 00936-8344, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 24926950 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie, (prior sponsor, Abbott)

800-633-9110

Study Officials

• Peter Bacher, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 9, 2014
• Results First Posted: December 10, 2013

Record last verified: 2014-01

Locations

US (16); PR (4)