Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
1 other identifier
interventional
325
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 28, 2007
December 1, 2007
October 5, 2005
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Phoenix, Arizona, 85105, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
North Port Richey, Florida, 34652, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Pottstown, Pennsylvania, 19464, United States
Related Publications (1)
Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
PMID: 27676118DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 7, 2005
Study Start
October 1, 2005
Study Completion
February 1, 2007
Last Updated
December 28, 2007
Record last verified: 2007-12