Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had One or More Adverse Events
研究概览
简要总结
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
详细描述
The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.
This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.
The survey will enroll approximately 300 patients.
- Leuprorelin
This multi-center survey will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with premenopausal breast cancer will be included.
排除标准
- •Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
- •Pregnant or potentially pregnant participants and breastfeeding participants
研究组 & 干预措施
Leuprorelin acetate
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Events
时间窗: Up to Week 24
次要结局
- Percentage of Participants Who Had One or More Adverse Reactions(Up to Week 24)