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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00234819
First received: October 5, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause

Additional relevant MeSH terms:
Bazedoxifene
Estrogens
Estrogens, Conjugated (USP)
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on November 23, 2014