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

Sponsored by:	Abbott
Information provided by:	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 (12 months).

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

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A 12 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

Further study details as provided by Abbott:

Primary Outcome Measures:

Suppression of luteinizing hormone concentrations (<4 mIU/mL). [ Time Frame: Months 6 and 12 ] [ 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: Months 6 and 12 ] [ Designated as safety issue: Yes ]
Peak stimulated luteinizing hormone concentrations. [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
Suppression of the physical signs of puberty. [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
Change from baseline (from the lead-in study) in growth rate within each of the subgroups of children not previously treated and and previously treated. [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
The ratio of change from baseline (form the lead-in study) in bone age/change from baseline in chronological age within each of the subgroups of children not previously treated and previously treated. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	December 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Leuprolide acetate 11.25 mg Four intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
2: Experimental	Drug: Leuprolide acetate 30 mg Four intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.

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 12 month open-label extension study. Subjects will receive a total of four (4) 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 administered 3 months apart. This study includes a 12-month treatment period (four 3-month treatment cycles), and a posttreatment follow-up period (12 weeks following the Month 12 visit). Study visits will occur at Day 1, Months 3, 6, 9 and 12, and 12 weeks later, for the Posttreatment 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 (premature thelarche, premature adrenarche).
Bone age >14 years for girls and >15 years for boys
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

Contacts

Contact: Abbott Global Medical Services

800-633-9110

Locations

United States, Florida
	Recruiting
Jacksonville, Florida, United States, 32207
United States, Missouri
	Recruiting
Kansas City, Missouri, United States, 64108
United States, Oklahoma
	Recruiting
Tulsa, Oklahoma, United States, 74135
United States, Washington
	Recruiting
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Peter Bacher, Global Project Head )
Study ID Numbers:	L-CP07-177
Study First Received:	April 24, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00667446 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

CPP
central precocious puberty
pediatrics
suppression of LH
Lupron
leuprolide acetate

depot formulation
GnRHa
GnRH agonist
GNRH analog
LH
Tanner staging

Study placed in the following topic categories:

Deslorelin
Antineoplastic Agents, Hormonal
Leuprolide
Gonadal Disorders

Puberty, Precocious
Precocious Puberty
Endocrine System Diseases
Endocrinopathy

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Leuprolide
Gonadal Disorders
Puberty, Precocious
Fertility Agents, Female

Therapeutic Uses
Physiological Effects of Drugs
Fertility Agents
Endocrine System Diseases
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009