A Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)
研究概览
简要总结
A multicenter, open-label, prospective study to evaluate the safety and efficacy of leuprorelin acetate DPS (Leuplin DPS) treatment quarterly in patients with central precocious puberty
详细描述
Type and design of study (eg, parallel, crossover, double-blind, open, superiority, noninferiority).Blinding measures taken to minimize bias (eg, "single-blind; subjects receive blinded study medication").
A single arm, multicenter, open-label, prospective study. Requirements for run-in or washout of medication. Those who have been administered one of the following drugs within 2 weeks before they start to participate in this study
- Estrogens
- Antiestrogens
- Progesterones
- Steroids
- Oriental medicines
Description of population to be studied (eg, adults with chronic heart failure and ejection fraction below 40% or subjects with uncontrolled, long-term type 2 diabetes).
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
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female children aged '≥ 4 years ~ < 9 years (8 years plus 364 days)
- •Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
- •Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
- •Those whose bone age increased by one year or more compared to their chronological age
- •Subjects and their guardians who gave written consent to participate in this study
排除标准
- •Those whose bone age is 11 years and 6 months or older
- •Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
- •Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
- •Those who have received GnRH analog treatment
- •Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
- •Those receiving growth hormone
- •Those who are suspected of or diagnosed with malignant tumor
- •Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion
- •Those who have been administered one of the following drugs within 2 weeks before they started to participate in this study, or who are expected to be administered during the study period
- •Estrogens
- •Antiestrogens
- •Progesterones
- •Oriental medicines
- •Those who have participated in another clinical study within 90 days from the date when the IP was administered
- •Those who are found to be ineligible for this study in the investigator's opinion
研究组 & 干预措施
Leuplin DPS 11.25mg s.c. every 12 weeks
Open
干预措施: Leuplin DPS 11.25mg (Drug)
结局指标
主要结局
Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)
时间窗: at 24 weeks
Percentage(%) of subjects with inhibition of LH response (peak \<3mIU/mL) maintained upon GnRH stimulation test at 12, 24, and 48 weeks
次要结局
- LH peak/FSH ratio maintained to be <1 upon(at 12, 24, and 48 weeks)
研究者
Jin Soon Hwang
Professor
Ajou University School of Medicine