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

Wyeth is now a wholly owned subsidiary of Pfizer650 enrolled

Overview

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

650

Conditions

Vaginal Atrophy

Interventions

Bazedoxifene/Conjugated EstrogenDRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Generally healthy, postmenopausal women, aged 40 to 65 years * Intact uterus * At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome Exclusion Criteria: * Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia * Thrombophlebitis, thrombosis or thromboembolic disorders * Neuro-ocular disease

Locations (63)

Outcomes

Primary Outcomes

Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Secondary Outcomes

Vaginal pH at screening, and weeks 4 and 12.

Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Montgomery, Alabama, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Oakland, California, United States

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San Diego, California, United States

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Upland, California, United States

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Denver, Colorado, United States

Unnamed facility

Avon, Connecticut, United States

Unnamed facility

Groton, Connecticut, United States

...and 53 more locations