NCT00564850已完成3 期
Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 37
- 试验地点
- 18
- 主要终点
- Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
研究概览
简要总结
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
- •Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
- •Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).
- •The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.
研究组 & 干预措施
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Experimental
干预措施: Triptorelin pamoate 11.25mg (Decapeptyl® SR) (Drug)
结局指标
主要结局
Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
时间窗: 3 months after the first injection of triptorelin pamoate 11.25 mg
次要结局
- Basal FSH Level(Month 0, 1, 2, 3, 4, 5, and 6)
- Number of Girls With Oestradiol Levels ≤ 20 pg/ml(Month 0, 1, 2, 3, 4, 5 and 6)
- Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L(Month 6)
- Difference Between Bone Age and Chronological Age(Month 0 and 6)
- Basal LH Level(Month 0, 1, 2, 3, 4, 5 and 6)
- Change From Baseline in Growth Velocity (GV) SDS at Month 6(Baseline and month 6)
- Triptorelin Plasma Levels(Month 1, 2, 3, 4, 5 and 6)
- Follicle Stimulating Hormone (FSH) Level Following GnRH Test(Screening, month 3 and 6)
- Testosterone Level(Month 0, 3 and 6)
- Body Mass Index (BMI) SDS(Month 0, 3 and 6)
- Number of Girls With Inhibin B Levels < 6 pg/ml(Month 0, 3 and 6)
- Change From Screening in Pubertal Stage (Tanner Method) at Month 6(Between screening and month 6)
- Height Standard Deviation Score (SDS)(Month 0, 3 and 6)
- Uterine Length(Month 0, 3 and 6)
研究者
研究点 (18)
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