jRCT2080223763已完成3 期
Open label study of FSN-011-01 in Japanese women with menopausal disorder with uterus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Non-randomized multicenter open trial
- 主要目的
- Prevention Purpose
入排标准
- 年龄范围
- 45age old over 至 64age old under（—）
- 性别
- Female
入选标准
- •Japanese menopausal women with uterus to undergo hormone replacement therapy
排除标准
- •Subjects who are positive or indeterminable with 5 mm or more of endometrial thickness in endometrial biopsy
- •Subjects who are not able to undergo endometrial biopsy procedurally due to cervical stenosis, etc. at screening (Visit 1).
- •Subjects who have serious liver injury at screening (Visit 1)
- •Subjects who have or are suspected to have malignant tumor at screening (Visit 1)
- •Subjects who have past medical history of breast cancer
结局指标
主要结局
-
efficacy Incidence of endometrial hyperplasia
次要结局
未报告次要终点
研究者
研究点 (1)
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