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

December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Montgomery, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Oakland, California, United States
      • San Diego, California, United States
      • Upland, California, United States, 91786
    • Colorado
      • Denver, Colorado, United States, 80202
    • Connecticut
      • Avon, Connecticut, United States
      • Groton, Connecticut, United States
      • Waterbury, Connecticut, United States
    • Florida
      • Aventura, Florida, United States, 33180
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Palm Harbor, Florida, United States
      • Palm Springs, Florida, United States
      • Pinnellas Park, Florida, United States
      • Stuart, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Conyers, Georgia, United States
      • Douglasville, Georgia, United States
      • Savannah, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Champaign, Illinois, United States
      • Chicago, Illinois, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Booklyn Center, Minnesota, United States
      • Chaska, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Kansas, Mississippi, United States
    • Missouri
      • Creve Cour, Missouri, United States
      • St. Louis, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Livingston, New Jersey, United States
      • New Brunswick, New Jersey, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
      • Jamestown, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Media, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Hilton Head Island, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Denton, Texas, United States
      • Galveston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3115A1-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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