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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00234819
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Vasomotor Symptoms Associated With Menopause Drug: Bazedoxifene/Conjugated Estrogen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234819


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85105
United States, Florida
Ft. Myers, Florida, United States, 33916
North Port Richey, Florida, United States, 34652
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 is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00234819    
Other Study ID Numbers: 3115A1-305
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause
Additional relevant MeSH terms:
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Bazedoxifene
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents