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

This study has been completed.

First Received: October 5, 2005 Last Updated: December 19, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00234819

Purpose

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.

Condition	Intervention	Phase
Vasomotor Symptoms Associated With Menopause	Drug: Bazedoxifene/Conjugated Estrogen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	325
Study Start Date:	October 2005
Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	40 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234819

Locations

United States, Arizona

Phoenix, Arizona, United States, 85105
United States, Florida

North Port Richey, Florida, United States, 34652

Ft. Myers, Florida, United States, 33916
United States, Maine

Scarborough, Maine, United States, 04074
United States, New Mexico

Albuquerque, New Mexico, United States, 87102
United States, North Carolina

Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania

Pottstown, Pennsylvania, United States, 19464

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3115A1-305
Study First Received:	October 5, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00234819 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Menopause

Additional relevant MeSH terms:

Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010