Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Completed · Phase 3 · Has a placebo group
Conditions studied: Menopause, Osteoporosis
In brief
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.
Key facts
- Study ID
- NCT00808132
- Run by
- Pfizer
- People needed
- 1886
- Starts
- 2009-01-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2014-04-08
Who can join
Age: 40 and older, up to 64. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
- Intact Uterus
You may not qualify if…
- Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
- A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
Where it is running
- Pfizer Investigational Site — Mobile, Alabama, United States
- Pfizer Investigational Site — Chandler, Arizona, United States
- Pfizer Investigational Site — Glendale, Arizona, United States
- Pfizer Investigational Site — Mesa, Arizona, United States
- Pfizer Investigational Site — Peoria, Arizona, United States
- Pfizer Investigational Site — Phoenix, Arizona, United States
- Pfizer Investigational Site — Scottsdale, Arizona, United States
- Pfizer Investigational Site — Tucson, Arizona, United States
- Pfizer Investigational Site — Tucson, Arizona, United States
- Pfizer Investigational Site — Tucson, Arizona, United States
- Pfizer Investigational Site — Little Rock, Arkansas, United States
- Pfizer Investigational Site — Carmichael, California, United States
- Pfizer Investigational Site — Sacramento, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — Upland, California, United States
- Pfizer Investigational Site — Vista, California, United States
- Pfizer Investigational Site — Walnut Creek, California, United States
- Pfizer Investigational Site — Colorado Springs, Colorado, United States
- Pfizer Investigational Site — Colorado Springs, Colorado, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Lakewood, Colorado, United States
- Pfizer Investigational Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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