Official Title: “A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

Intervention(s) in this Clinical Trial

• Drug: Bazedoxifene/Conjugate Estrogens (CE)
• Drug: Raloxifene
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B
• Placebo Comparator: C

Primary Measures

• To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
  • Time Frame: one year
    Safety Issue?: Yes

Secondary Measures

• To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.
  • Time Frame: one year
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675688

Study ID Number: 3115A1-303

ClinicalTrials.gov Identifier: NCT00675688

Health Authority: United States: Food and Drug Administration