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

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

A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

325

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
    • Arizona
      • Phoenix, Arizona, United States, 85105
    • Florida
      • Ft. Myers, Florida, United States, 33916
      • North Port Richey, Florida, United States, 34652
    • Maine
      • Scarborough, Maine, United States, 04074
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
  • Intact uterus
  • Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria:

  • History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
  • History of active presence of stroke, TIA, heart attack or ischemic heart disease
  • History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.

Secondary Outcome Measures

Outcome Measure
Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.

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)

February 1, 2007

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 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

  • 3115A1-305

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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