Open label study of FSN-011-01 in Japanese women with menopausal disorder with uterus

Fuji Pharma, Co, Ltd0 个研究点目标入组 350 人开始时间: 2017年12月25日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Fuji Pharma, Co, Ltd
入组人数: 350

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

After co-administration of FSN-011-01 with estrogen preparation for 52 weeks, no endometrial hypertrophy was observed. It was confirmed that the upper boundary of the two-sided 95% confidence interval for the incidence was below the predetermined level of 2.0%. Regarding safety, the majority of subjects completed the trial, so there were no major tolerability concerns.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 45age old 至 <= 64age old（—）
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

研究者

发起方

Fuji Pharma, Co, Ltd

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