NCT07710430招募中4 期
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty
LG Chem1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
研究概览
简要总结
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious 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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tanner stage =>2
- •Girls younger than 9 years old, boys younger than 10 years old
- •Subjects who are diagnosed with central precocious puberty (CPP)
排除标准
- •GnRH-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma
- •Hepatic impairment or abnormal liver function tests at screening
- •Renal impairment or abnormal renal function at screening
- •Use of following within 8 weeks prior to screening or during the study: medications affecting gonadotropin or sex hormone, systemic steroids, herbal medications
- •Use of medications associated with seizures
- •Requirement for treatments affecting the hypothalamic-pituitary-gonadal axis
- •History of seizures, epilepsy, cerebrovascular disease, or central nervous system disorders/tumors
- •Known or suspected malignancy
研究组 & 干预措施
Leuprorelin
Experimental
干预措施: Leuprorelin (Drug)
结局指标
主要结局
Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L).
时间窗: 24 weeks after treatment initiation
次要结局
- Changes from baseline in endocrine function: basal LH in IU/L, follicle-stimulating hormone (FSH) in IU/L, testosterone (T) in nanograms per deciliter (ng/dL), estradiol (E2) in picograms per milliliter (pg/mL)(Up to 96 weeks after treatment initiation)
- Changes from baseline in pubertal development: Tanner stage(Up to 96 weeks after treatment initiation)
- Changes from baseline in growth related parameters: height in centimeter, weight in kilograms(Up to 96 weeks after treatment initiation)
- Safety: Number of participants with treatment-related adverse events as assessed by the investigator(Up to 96 weeks after treatment initiation)
- Peak LH level following GnRH stimulation is < 4 IU/L at 48, 96wk(48 weeks and 96 weeks after treatment initiation)
- Changes from baseline in growth related parameters: height in centimeter(Up to 96 weeks after treatment initiation)
- Changes from baseline in growth related parameters: weight in kilograms(Up to 96 weeks after treatment initiation)
研究者
研究点 (1)
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