Clinical trial NCT00667446: Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) 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 criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
timeFrame: Day 1, Months 6, 12, 24, and 36
Secondary outcomes:
measure: Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
timeFrame: Day 1, Months 3, 6, 9, 12, and 24
measure: Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
timeFrame: Months 6, 9, 12, 24, 30, and 36
measure: Percentage of Male Participants With Suppression of Basal Testosterone
timeFrame: Day 1, Months 3, 6, 9, 12, 24, 30, and 36
measure: Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
timeFrame: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36
measure: Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
timeFrame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
timeFrame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: Change From Baseline in Growth Rate
timeFrame: Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36
measure: Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
timeFrame: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 13521
state: Alabama
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 14922
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 26043
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 20802
state: California
city: Greenwood Village
country: United States
facility: Site Reference ID/Investigator# 22425
state: Colorado
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 18181
state: Florida
city: Pensacola
country: United States
facility: Site Reference ID/Investigator# 26364
state: Florida
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 26983
state: Indiana
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 20821
state: Louisiana
city: Minneapolis
country: United States
facility: Site Reference ID/Investigator# 23643
state: Minnesota
city: St. Paul
country: United States
facility: Site Reference ID/Investigator# 23502
state: Minnesota
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 14121
state: Missouri
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 23802
state: Oklahoma
city: Tulsa
country: United States
facility: Site Reference ID/Investigator# 13324
state: Oklahoma
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 16506
state: Pennsylvania
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 14024
state: Washington
city: Bayamon
country: Puerto Rico
facility: Site Reference ID/Investigator# 23182
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 21721
city: Rio Piedras
country: Puerto Rico
facility: Site Reference ID/Investigator# 25908
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 23082
Study officials:
affiliation: AbbVie
name: Peter Bacher, MD
role: STUDY_DIRECTOR
References:
citation: 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.