Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
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
1 other identifier
interventional
650
1 country
63
Brief Summary
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedDecember 28, 2007
December 1, 2007
October 12, 2005
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy, postmenopausal women, aged 40 to 65 years
- Intact uterus
- At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome
You may not qualify if:
- Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
- Thrombophlebitis, thrombosis or thromboembolic disorders
- Neuro-ocular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
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Birmingham, Alabama, United States
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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, 91786, United States
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Denver, Colorado, 80202, United States
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Avon, Connecticut, United States
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Groton, Connecticut, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, 33180, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Palm Harbor, Florida, United States
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Palm Springs, Florida, United States
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Pinnellas Park, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, 30328, United States
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Conyers, Georgia, United States
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Douglasville, Georgia, United States
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Savannah, Georgia, United States
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Idaho Falls, Idaho, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Booklyn Center, Minnesota, United States
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Chaska, Minnesota, United States
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Jackson, Mississippi, United States
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Kansas, Mississippi, United States
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Creve Cour, Missouri, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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Livingston, New Jersey, United States
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New Brunswick, New Jersey, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Jamestown, North Dakota, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Erie, Pennsylvania, United States
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Media, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Hilton Head Island, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Galveston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
Related Publications (2)
Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.
PMID: 37619252DERIVEDPinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.
PMID: 28539177DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 13, 2005
Study Start
October 1, 2005
Study Completion
March 1, 2007
Last Updated
December 28, 2007
Record last verified: 2007-12