A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,083
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD) of Lumbar Spine at Screening
研究概览
简要总结
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Generally healthy, postmenopausal women, aged 40 to less than 65 years
- •Intact uterus
- •At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL.
排除标准
- •Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
- •A history or active presence of clinically important medical disease
- •Malabsorption disorders
研究组 & 干预措施
1
BZA 20mg/CE 0.625
干预措施: Bazedoxifene/Conjugated Estrogen (Drug)
Arm 2
BZA 20mg/CE 0.45
干预措施: Bazedoxifene/Conjugated Estrogen (Drug)
Arm 3
CE 0.45mg/MPA1.5mg
干预措施: CE 0.45 mg/MPA 1.5mg (Drug)
Arm 4
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Bone Mineral Density (BMD) of Lumbar Spine at Screening
时间窗: Screening
BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
时间窗: Baseline, Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Bone Mineral Density (BMD) of Total Hip at Screening
时间窗: Screening
BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Percentage of Participants With Hyperplasia at Screening
时间窗: Screening
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Percentage of Participants With Hyperplasia at Month 12
时间窗: Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
时间窗: Baseline, Month 12
BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
次要结局
- Percentage of Days With Breast Pain(Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52)
- Percentage of Participants With Uterine Bleeding or Spotting(Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52)
- Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24(Baseline, Month 24)
- Percentage of Participants With Hyperplasia at Month 24(Month 24)
- Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24(Baseline, Month 24)