A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On 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
- 1,886
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
- •At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
- •Intact Uterus
排除标准
- •Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
- •A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
研究组 & 干预措施
1
bazedoxifene 20 mg/conjugated estrogens 0.45 mg
干预措施: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg (Drug)
2
bazedoxifene 20 mg/conjugated estrogens 0.625 mg
干预措施: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg (Drug)
3
bazedoxifene 20 mg
干预措施: bazedoxifene 20 mg (Drug)
4
Prempro
干预措施: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg (Drug)
5
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
时间窗: Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
时间窗: Baseline, Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.
次要结局
- Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study(Baseline, Month 6)
- Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study(Baseline, Month 6, Month 12)
- Percentage of Participants With Cumulative Amenorrhea: Main Study(Day 1 up to Day 364)
- Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study(Baseline, Month 12)
- Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study(Baseline, Month 6, 12)
- Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study(Baseline)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study(Baseline, Month 3)
- Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study(Baseline)
- Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study(Baseline, Month 3)
- Percentage of Participants With Uterine Bleeding(Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52)