A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
Phase 3
40 Years
64 Years
40 Years
64 Years
Not Enrolling
Female
Menopause, Osteoporosis
Female
Menopause, Osteoporosis
Trial Information
A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence of Endometrial Hyperplasia and Changes in Bone Mineral Density
Outcome Time Frame:
1 Year
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3115A1-3307
NCT ID:
NCT00808132
Start Date:
January 2009
Completion Date:
February 2011
Related Keywords:
- Menopause
- Osteoporosis
- Postmenopausal Women
- Bazedoxifene/Conjugated Estrogens
- Endometrial Hyperplasia
- Osteoporosis
- Osteoporosis, Postmenopausal
- Adenoma
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Flagstaff, Arizona 86001 |
| Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Kansas City, Kansas 66112 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Las Vegas, Nevada 89128 |
| Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Livingston, New Jersey 07039 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
| Pfizer Investigational Site | Billings, Montana 59101 |
| Pfizer Investigational Site | Lebanon, New Hampshire 03766 |
| Pfizer Investigational Site | Lewistown, Idaho 83501 |
| Pfizer Investigational Site | Bangor, Maine 04401 |
| Pfizer Investigational Site | Bismarck, North Dakota 58503 |
| Pfizer Investigational Site | Aberdeen, South Dakota 57401 |
| Pfizer Investigational Site | Providence, Rhode Island 02906 |
