NCT01634321已完成4 期
The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
研究概览
简要总结
The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •4~8 years & tanner stage ≥ 2
排除标准
- •Previous treatment with GnRH analog therapy
研究组 & 干预措施
Luphere
Experimental
干预措施: Luphere depot 3.75mg(Leuprolide acetate 3.75mg) (Drug)
结局指标
主要结局
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
时间窗: At 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
4 期
A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in IndiaAnemiaNCT05891249Bristol-Myers Squibb85
已完成
4 期
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA StudySjögren SyndromeHyposalivationHead and Neck CancerXerostomiaNCT02049112Unither Pharmaceuticals, France210
终止
4 期
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe DiseasePompe DiseaseNCT01526785Genzyme, a Sanofi Company113
已完成
4 期
The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A VaccinesHepatitis ANCT01949857Institute of Medical Biology, Chinese Academy of Medical Sciences35,000
已完成
4 期
Efficacy Trial of a Commercial EV71 VaccineHand, Foot and Mouth DiseaseNCT03903926Sinovac Biotech Co., Ltd15,500