Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty - Full Text View

Sponsor:	Abbott
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00667446

Purpose

The purpose of this 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).

Condition	Intervention	Phase
Puberty Precocious	Drug: Leuprolide acetate 11.25 mg Drug: Leuprolide acetate 30 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Puberty

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Suppression of peak-stimulated luteinizing hormone concentrations (< 4 mIU/mL). [ Time Frame: Day 1, Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Suppression of sex steroids (estradiol < 20 pg/mL in girls and testosterone < 30 ng/dL in boys). [ Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]
Basal
Peak stimulated luteinizing hormone concentrations. [ Time Frame: Day 1, Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]
Suppression of the physical signs of puberty. [ Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]
Change from baseline (from the lead-in study) in growth rate. [ Time Frame: Day 1, Months 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]
The ratio of change from baseline (from the lead-in study) in bone age/change from baseline in chronological age. [ Time Frame: Day 1, Months 12, 24, and 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Leuprolide acetate 11.25 mg	Drug: Leuprolide acetate 11.25 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart. Other Name: ABT-818, leuprolide acetate, Lupron
Experimental: Leuprolide acetate 30 mg	Drug: Leuprolide acetate 30 mg Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. Other Name: ABT-818, leuprolide acetate, Lupron

Detailed Description:

Approximately 70 subjects with Central Precocious Puberty from approximately 25 sites who completed the treatment period of the lead-in study, L-CP07-167, will enter this 36 month open-label extension study.

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).

Subjects will receive a total of twelve (12) injections of the same treatment they received in the lead-in study, 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

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Subject completed the Treatment Period of the lead-in study, L-CP07-167, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667446

Locations

United States, Alabama
Site Reference ID/Investigator# 13521
Birmingham, Alabama, United States, 35233
United States, California
Site Reference ID/Investigator# 14922
Long Beach, California, United States, 90806
Site Reference ID/Investigator# 26043
Los Angeles, California, United States, 90027
Site Reference ID/Investigator# 20802
San Diego, California, United States, 92123
United States, Colorado
Site Reference ID/Investigator# 22425
Greenwood Village, Colorado, United States, 80111
United States, Florida
Site Reference ID/Investigator# 18181
Jacksonville, Florida, United States, 32207
Site Reference ID/Investigator# 26364
Pensacola, Florida, United States, 32504
United States, Indiana
Site Reference ID/Investigator# 26983
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Site Reference ID/Investigator# 20821
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Site Reference ID/Investigator# 23643
Minneapolis, Minnesota, United States, 55455
Site Reference ID/Investigator# 23502
St. Paul, Minnesota, United States, 55102
United States, Missouri
Site Reference ID/Investigator# 14121
Kansas City, Missouri, United States, 64108
United States, Oklahoma
Site Reference ID/Investigator# 23802
Oklahoma City, Oklahoma, United States, 73104
Site Reference ID/Investigator# 13324
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Site Reference ID/Investigator# 16506
Hershey, Pennsylvania, United States, 17033
United States, Washington
Site Reference ID/Investigator# 14024
Seattle, Washington, United States, 98104
Puerto Rico
Site Reference ID/Investigator# 23182
Bayamon, Puerto Rico, 00960
Site Reference ID/Investigator# 21721
Ponce, Puerto Rico, 00717-2116
Site Reference ID/Investigator# 25908
San Juan, Puerto Rico, 18637
Site Reference ID/Investigator# 23082
San Juan, Puerto Rico, 00936-8344

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Peter Bacher, MD

Abbott

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00667446 History of Changes
Other Study ID Numbers:	L-CP07-177
Study First Received:	April 24, 2008
Last Updated:	January 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Central Precocious Puberty
CPP
Pediatrics
Luteinizing hormone (LH)
Suppression of LH
Lupron

Leuprolide acetate
Depot formulation
Gonadotrophin-releasing hormone (GnRH)
Gonadotrophin-releasing hormone agonist(GnRHa)
GnRH analog
Tanner staging

Additional relevant MeSH terms:

Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012