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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00675688

Collaborator

(none)

3,544

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Hyperplasia Osteoporosis	Drug: Bazedoxifene/Conjugate Estrogens (CE) Drug: Raloxifene Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

3544 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Bazedoxifene/Conjugate Estrogens (CE)
Active Comparator: B	Drug: Raloxifene
Placebo Comparator: C	Drug: Placebo

Arm

Intervention/Treatment

Experimental: A

Drug: Bazedoxifene/Conjugate Estrogens (CE)

Active Comparator: B

Drug: Raloxifene

Placebo Comparator: C

Drug: Placebo

Outcome Measures

Primary Outcome Measures

To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. [one year]

Secondary Outcome 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. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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.