Clinical Trial: Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Men
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.
Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: October 5, 2005
Date Started: October 2005
Date Completion:
Last Updated: December 19, 2007
Last Verified: December 2007