An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Tolmar Inc.
- 入组人数
- 64
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
研究概览
简要总结
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
详细描述
Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
- •Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
- •Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
- •Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
- •Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
排除标准
- •Gonadotropin-independent (peripheral) precocious puberty
- •Prior or current GnRH treatment for CPP
- •Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
- •Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
- •Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
- •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
研究组 & 干预措施
Assigned Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
干预措施: Leuprolide Acetate 45 mg (Drug)
结局指标
主要结局
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
时间窗: 6 months
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
次要结局
- Percent Change From Baseline in Height(Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48)
- Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.(Week 12, Week 24, Week 36, and Week 48)
- Changes in Height Velocity (Growth Rate)(Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48)
- Bone Age Ratio to Chronological Age at Time of Measurement(Week 24 and Week 48)
- Tanner Scores: Boys - Development of External Genitalia(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Tanner Scores: Boys and Girls - Pubic Hair(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)(Week 12, Week 24, Week 36, and Week 48)
- Tanner Scores: Girls - Breast Development(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)(Week 12, Week 24, Week 36, and Week 48)
- Tanner Scores: Girls - Breast Development (Change From Baseline)(Week 12, Week 24, Week 36, and Week 48)