Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

Wyeth is now a wholly owned subsidiary of Pfizer325 enrolled

Overview

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

325

Conditions

Vasomotor Symptoms Associated With Menopause

Interventions

Bazedoxifene/Conjugated EstrogenDRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago * Intact uterus * Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week Exclusion Criteria: * History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders * History of active presence of stroke, TIA, heart attack or ischemic heart disease * History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Locations (7)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Fort Myers, Florida, United States

Unnamed facility

North Port Richey, Florida, United States

Unnamed facility

Scarborough, Maine, United States

Outcomes

Primary Outcomes

Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.

Secondary Outcomes

Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.

Data from ClinicalTrials.gov

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