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
Overview
- Phase
- Phase 3
- Intervention
- bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
- Conditions
- Menopause
- Sponsor
- Pfizer
- Enrollment
- 1886
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
1
bazedoxifene 20 mg/conjugated estrogens 0.45 mg
Intervention: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
2
bazedoxifene 20 mg/conjugated estrogens 0.625 mg
Intervention: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
3
bazedoxifene 20 mg
Intervention: bazedoxifene 20 mg
4
Prempro
Intervention: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
5
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)