A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 662
- 主要终点
- Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)
研究概览
简要总结
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
- •Non-hysterectomized women.
排除标准
- •Usual exclusion criteria for hormone therapy apply.
研究组 & 干预措施
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
干预措施: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (Drug)
0.5mg NETA / 1.0mg E2 (Activella)
One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
干预措施: 0.5mg NETA / 1.0mg E2 (Activella) (Drug)
结局指标
主要结局
Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)
时间窗: Up to one year
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
次要结局
- Number of Participants With Amenorrhea During Month 1 to 3 of Treatment(Month 1 to Month 3)
- Number of Participants With Amenorrhea During Month 10 to 12 of Treatment(Month 10 to Month 12)