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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Leuprolide Acetate 3M Depot 11.25 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart.
干预措施: Leuprolide Acetate 3 Month Depot (Drug)
Leuprolide Acetate 3M Depot 30 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
干预措施: Leuprolide Acetate 3 Month Depot (Drug)
结局指标
主要结局
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
时间窗: Day 1, Months 6, 12, 24, and 36
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
次要结局
- Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)(Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36)
- Mean Peak-stimulated Luteinizing Hormone Concentration by Visit(Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36)
- Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)(Day 1, Months 3, 6, 9, 12, and 24)
- Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)(Months 6, 9, 12, 24, 30, and 36)
- Percentage of Male Participants With Suppression of Basal Testosterone(Day 1, Months 3, 6, 9, 12, 24, 30, and 36)
- Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)(Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36)
- Change From Baseline in Growth Rate(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)
- Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age(Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36)