Conditions: Endometrial Hyperplasia Osteoporosis
Keywords: Endometrium Uterus Menopause
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1083
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: BZA 20mg/CE 0.625 arm 2: BZA 20mg/CE 0.45 arm 3: CE 0.45mg/MPA1.5mg arm 4: Placebo

Interventions: intervention 1: Bazedoxifene/Conjugated Estrogen intervention 2: Bazedoxifene/Conjugated Estrogen intervention 3: CE 0.45 mg/MPA 1.5mg intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 2: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 3: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 4: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Protocol document: