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

NCT ID: NCT00238732

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Vaginal Atrophy

Keywords

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Vaginal Atrophy Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Bazedoxifene/Conjugated Estrogen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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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, United States

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Denver, Colorado, 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, 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, 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

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37619252 (View on PubMed)

Pinkerton 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.

Reference Type DERIVED
PMID: 28539177 (View on PubMed)

Other Identifiers

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3115A1-306

Identifier Type: -

Identifier Source: org_study_id