Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Wyeth

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Endometrial Hyperplasia

Treatments: Drug: Raloxifene; Drug: Bazedoxifene/Conjugate Estrogens (CE); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675688

3115A1-303

Details and patient eligibility

About

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.

Enrollment: 3,544 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, postmenopausal women aged 40 - 75 years inclusive
• Intact uterus
• Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion criteria

• A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
• A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
• A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

3,544 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Bazedoxifene/Conjugate Estrogens (CE)

B

Active Comparator group

Treatment:

Drug: Raloxifene

C

Placebo Comparator group

Treatment:

Drug: Placebo