A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

NCT00635817 | Completed Phase 3 Results

• 1 other identifier: L-CP07-167
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 25

Brief Summary

The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).

Conditions

Puberty, Precocious

Keywords

CPP; central precocious puberty; pediatrics; suppression of luteinizing hormone; Lupron; leuprolide acetate; depot formulation; GnRHa; GnRH agonist; GnRH analog; luteinizing hormone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6

  Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.

  Month 2 through 6

Secondary Outcomes (7)

• Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit

  Month 1, 2, 3 and 6

• Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit

  Month 1, 2, 3 and 6

• Peak-stimulated Luteinizing Hormone Concentration by Visit

  Baseline, Month 1, 2, 3 and 6

• Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6

  Month 6

• Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6

  Month 6

Study Arms (2)

Leuprolide acetate 11.25 mg

EXPERIMENTAL

There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B.

Drug: Leuprolide acetate 11.25 mg

Leuprolide acetate 30 mg

EXPERIMENTAL

There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D.

Drug: Leuprolide acetate 30 mg

Interventions

Leuprolide acetate 11.25 mg DRUG

Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.

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

Leuprolide acetate 11.25 mg

Leuprolide acetate 30 mg DRUG

Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.

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

Leuprolide acetate 30 mg

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject has a clinical diagnosis of CPP.
• Eligible to receive at least 6 mo of therapy to treat CPP after study entry.
• Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment.
• 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.
• Additional criteria for subjects who have not had previous treatment:
• Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1.
• Has pretreatment pubertal response to leuprolide acetate stimulation (luteinizing hormone ≥8 mIU/mL) at Screening.
• Breast pubertal staging of at least 2 in girls; testicular volume of at least 4 cc or testicular length greater than 2.5 cm in boys at Screening.
• Additional criteria for subjects previously treated:
• Girls 2-10 years inclusive or boys 2-11 years inclusive at Day 1.
• Must have been on standard gonadotropin releasing hormone analog therapy for at least the 6 mo prior to Day 1.
• Has documented maintenance of luteinizing hormone suppression as evidenced by peak stimulated level \<4 mIU/mL at Screening.

You may not qualify if:

• Incomplete precocious puberty (premature thelarche, premature adrenarche).
• Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal hyperplasia, testotoxicosis in boys, human chorionic gonadotropin secreting tumor or McCune-Albright syndrome in girls.
• Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function other than premature secretion of gonadotropins not adequately controlled.
• Unstable intracranial tumors (unresponsive to treatment/expanding) except hamartoma.
• Previous treatment with GnRHa therapy requiring leuprolide acetate for depot suspension \>15 mg monthly.
• Bone age \>13 years for girls and \>14 years for boys.
• Any other condition interfering with growth, ie, skeletal dysplasia, cerebral palsy.
• Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
• Diagnosis of short stature, ie more than 2.25 standard deviations below the mean height for age (growth chart measurement).
• Prior or current therapy with medroxyprogesterone acetate or growth hormone.
• Has an abnormal laboratory value suggesting a clinically significant underlying disease .
• Creatinine \>1.5 mg/dL, alanine aminotransferase and/or aspartate aminotransferase \>2.0 x upper limit of normal, or total bilirubin \>2.0 mg/dL with aspartate aminotransferase/alanine aminotransferase elevated above normal limits.
• Positive pregnancy test.
• Known hypersensitivity to study medication or its excipients.
• Participation in another drug research within 3 mo of enrollment into this study.

Sponsors & Collaborators

• Abbott: lead

Study Sites (25)

Site Reference ID/Investigator# 8765

Birmingham, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 11522

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 8756

Los Angeles, California, 90027, United States

Location

Site Reference ID/Investigator# 8755

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 8761

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 8772

Stanford, California, 94305-5208, United States

Location

Site Reference ID/Investigator# 8749

Greenwood Village, Colorado, 80111, United States

Location

Site Reference ID/Investigator# 8771

Gainesville, Florida, 32608, United States

Location

Site Reference ID/Investigator# 8764

Jacksonville, Florida, 32207, United States

Location

Site Reference ID/Investigator# 17621

Pensacola, Florida, 32504, United States

Location

Site Reference ID/Investigator# 8752

Indianapolis, Indiana, 46202, United States

Location

Site Reference ID/Investigator# 8766

Shreveport, Louisiana, 71103, United States

Location

Site Reference ID/Investigator# 8768

Minneapolis, Minnesota, 55455, United States

Location

Site Reference ID/Investigator# 17341

Saint Paul, Minnesota, 55102, United States

Location

Site Reference ID/Investigator# 8759

Kansas City, Missouri, 64108, United States

Location

Site Reference ID/Investigator# 8750

Oklahoma City, Oklahoma, 73104, United States

Location

Site Reference ID/Investigator# 8760

Tulsa, Oklahoma, 74135, United States

Location

Site Reference ID/Investigator# 8763

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 8754

Salt Lake City, Utah, 84108, United States

Location

Site Reference ID/Investigator# 8762

Seattle, Washington, 98104, United States

Location

Site Reference ID/Investigator# 8753

Seattle, Washington, 98105, United States

Location

Site Reference ID/Investigator# 17922

Bayamón, 00960, Puerto Rico

Location

Site Reference ID/Investigator# 17923

Ponce, 00717-2116, Puerto Rico

Location

Site Reference ID/Investigator# 18242

San Juan, 00936-5067, Puerto Rico

Location

Site Reference ID/Investigator# 19661

San Juan, 00936-8344, Puerto Rico

Location

Related Publications (1)

• Lee PA, Klein K, Mauras N, Neely EK, Bloch CA, Larsen L, Mattia-Goldberg C, Chwalisz K. Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty. J Clin Endocrinol Metab. 2012 May;97(5):1572-80. doi: 10.1210/jc.2011-2704. Epub 2012 Feb 16.

  PMID: 22344198 DERIVED

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: Abbott

800-633-9110

Study Officials

• Peter Bacher, MD,

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 2, 2011
• Results First Posted: February 9, 2011

Record last verified: 2011-10

Locations

PR (4); US (21)