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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00675688

Enrollment

3544

Registered

2008-05-12

Start date

2002-04-30

Completion date

2006-01-31

Last updated

2008-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Hyperplasia, Osteoporosis

Keywords

Menopause

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.

Interventions

DRUGBazedoxifene/Conjugate Estrogens (CE)

DRUGRaloxifene

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026