Study of Lupron Depot In The Treatment of Central Precocious Puberty

NCT00660010 | Completed Phase 3 Results

• 1 other identifier: M90-516
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

Conditions

Puberty, Precocious

Keywords

CPP; central precocious puberty; pediatrics; suppression of LH; Lupron; leuprolide acetate; depot formulation; GnRHa; GnRH agonist; GNRH analog; LH; Tanner staging

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)

  Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).

  Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

• Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)

  Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).

  Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Secondary Outcomes (4)

• Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations

  Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

• Mean Stimulated Estradiol Concentrations in Females

  Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

• Mean Stimulated Testosterone Concentrations in Males

  Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

• Mean Ratio of Bone Age to Chronological Age

  Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Other Outcomes (5)

• Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)

  Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)

• Mean Time to or Mean Age at Regular Menses in Females After Treatment

  Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)

• Number of Female Subjects Who Reported Regular Menses at Adulthood

  Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

Study Arms (1)

1

EXPERIMENTAL

Drug: Lupron (leuprolide acetate)

Interventions

Lupron (leuprolide acetate) DRUG

Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Also known as: Lupron

1

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
• Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH \> 10 U/L at baseline).
• Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
• Bone age advanced at least 1 year beyond the chronological age at entry into the study.
• The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.
• No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.

You may not qualify if:

• Irradiation to the central nervous system.
• Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

Sponsors & Collaborators

• Abbott: lead

Study Sites (9)

Site Reference ID/Investigator# 46673

Phoenix, Arizona, 85006, United States

Location

Site Reference ID/Investigator# 46671

San Francisco, California, 94122, United States

Location

Site Reference ID/Investigator# 14921

Stanford, California, 94305, United States

Location

Site Reference ID/Investigator# 14343

Aurora, Colorado, 80045, United States

Location

Site Reference ID/Investigator# 14341

St. Petersburg, Florida, 33701, United States

Location

Site Reference ID/Investigator# 14342

Indianapolis, Indiana, 46202, United States

Location

Site Reference ID/Investigator# 46672

Baltimore, Maryland, 21201, United States

Location

Site Reference ID/Investigator# 46668

Springfield, Massachusetts, 01199, United States

Location

Site Reference ID/Investigator# 14344

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Lee PA, Neely EK, Fuqua J, Yang D, Larsen LM, Mattia-Goldberg C, Chwalisz K. Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi: 10.1186/1687-9856-2011-7. Epub 2011 Jul 12.

  PMID: 21860633 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

Limitations and Caveats

Study drug was discontinued usually at the initiation of puberty (12 years for males and 11 years for females) with the concurrence of the investigator, or at the discretion of the investigator. Adverse events are coded with the COSTART dictionary.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott Laboratories

800-633-9110

Study Officials

• Kristof Chwalisz, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 1991
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 12, 2011
• Results First Posted: July 20, 2010

Record last verified: 2011-04

Locations

US (9)