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

Condition(s) targeted: Vaginal Atrophy

Intervention: Bazedoxifene/Conjugated Estrogen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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

Official title: A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women

Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome:

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 outcome:

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.

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Montgomery, Alabama, United States

Birmingham, Alabama, United States

Tucson, Arizona, United States

Scottsdale, Arizona, United States

Upland, California 91786, United States

San Diego, California, United States

Oakland, California, United States

Denver, Colorado 80202, United States

Avon, Connecticut, United States

Waterbury, Connecticut, United States

Groton, Connecticut, United States

Aventura, Florida 33180, United States

West Palm Beach, Florida, United States

Palm Springs, Florida, United States

Tampa, Florida, United States

Miami, Florida, United States

Stuart, Florida, United States

Pinnellas Park, Florida, United States

Palm Harbor, Florida, United States

Gainesville, Florida, United States

Atlanta, Georgia 30328, United States

Conyers, Georgia, United States

Douglasville, Georgia, United States

Savannah, Georgia, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Champaign, Illinois, United States

Kansas City, Kansas, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

Booklyn Center, Minnesota, United States

Chaska, Minnesota, United States

Jackson, Mississippi, United States

Kansas, Mississippi, United States

St. Louis, Missouri, United States

Creve Cour, Missouri, United States

Lebanon, New Hampshire, United States

New Brunswick, New Jersey, United States

Livingston, New Jersey, United States

Winston-Salem, North Carolina, United States

Jamestown, North Dakota, United States

Fargo, North Dakota, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Medford, Oregon, United States

West Reading, Pennsylvania, United States

Erie, Pennsylvania, United States

Media, Pennsylvania, United States

Hilton Head Island, South Carolina, United States

Sioux Falls, South Dakota, United States

Nashville, Tennessee, United States

Denton, Texas, United States

San Antonio, Texas, United States

Galveston, Texas, United States

Dallas, Texas, United States

Salt Lake City, Utah, United States

Burlington, Vermont, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Starting date: October 2005
Ending date: March 2007
Last updated: December 19, 2007