At a glance
ClinicalIndex Comparison Record- ✓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 FSH >40 mIU/mL
- ✕Use of oral estrogen-, progestin-, androgen-, or SERM-containing drugs within 8 weeks of screening (12 weeks for osteoporosis substudy)
- ✕History or active presence of clinically important medical disease
- ✕Malabsorption disorders
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bazedoxifene/Conjugated Estrogen, CE 0.45 mg/MPA 1.5mg, and 1 other intervention for Endometrial Hyperplasia and Osteoporosis. Completed, enrolled 1,083 participants across 9 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.