Conditions: Menopause Osteoporosis
Keywords: Postmenopausal Women Bazedoxifene/Conjugated Estrogens
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1886
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: bazedoxifene 20 mg/conjugated estrogens 0.45 mg arm 2: bazedoxifene 20 mg/conjugated estrogens 0.625 mg arm 3: bazedoxifene 20 mg arm 4: Prempro arm 5: Placebo

Interventions: intervention 1: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg intervention 2: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg intervention 3: bazedoxifene 20 mg intervention 4: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg intervention 5: Placebo
Intervention descriptions: intervention 1: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year. intervention 2: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year. intervention 3: One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year. intervention 4: One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year. intervention 5: One capsule, placebo (over-encapsulated), once a day for one year.

Protocol document: