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

Primary Purpose

Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bazedoxifene/Conjugated Estrogen
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vaginal Atrophy focused on measuring Vaginal Atrophy, Postmenopause

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
October 12, 2005
Last Updated
December 19, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00238732
Brief Title
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
Keywords
Vaginal Atrophy, Postmenopause

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
650 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bazedoxifene/Conjugated Estrogen
Primary Outcome Measure Information:
Title
Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Title
Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Secondary Outcome Measure Information:
Title
Vaginal pH at screening, and weeks 4 and 12.
Title
Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Montgomery
State/Province
Alabama
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Oakland
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
City
Avon
State/Province
Connecticut
Country
United States
City
Groton
State/Province
Connecticut
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Palm Springs
State/Province
Florida
Country
United States
City
Pinnellas Park
State/Province
Florida
Country
United States
City
Stuart
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Conyers
State/Province
Georgia
Country
United States
City
Douglasville
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Idaho Falls
State/Province
Idaho
Country
United States
City
Champaign
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Booklyn Center
State/Province
Minnesota
Country
United States
City
Chaska
State/Province
Minnesota
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Kansas
State/Province
Mississippi
Country
United States
City
Creve Cour
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Livingston
State/Province
New Jersey
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Jamestown
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Erie
State/Province
Pennsylvania
Country
United States
City
Media
State/Province
Pennsylvania
Country
United States
City
West Reading
State/Province
Pennsylvania
Country
United States
City
Hilton Head Island
State/Province
South Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Denton
State/Province
Texas
Country
United States
City
Galveston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28539177
Citation
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.
Results Reference
derived

Learn more about this trial

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

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