A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
Phase 3
40 Years
65 Years
40 Years
65 Years
Not Enrolling
Female
Endometrial Hyperplasia, Osteoporosis
Female
Endometrial Hyperplasia, Osteoporosis
Trial Information
A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
Inclusion Criteria:
- Generally healthy, postmenopausal women, aged 40 to less than 65 years
- Intact uterus
- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with
follicle-stimulating hormone (FSH) levels > 40 mIU/mL.
Exclusion Criteria:
- Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products
within 8 weeks before screening (12 weeks for the osteoporosis substudy)
- A history or active presence of clinically important medical disease
- Malabsorption disorders
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 year
Outcome Time Frame:
1 Year
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3115A1-304
NCT ID:
NCT00242710
Start Date:
September 2005
Completion Date:
September 2008
Related Keywords:
- Endometrial Hyperplasia
- Osteoporosis
- Endometrium
- Uterus
- Menopause
- Endometrial Hyperplasia
- Hyperplasia
- Osteoporosis
- Adenoma
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Billings, Montana 59101 |
| Pfizer Investigational Site | Honolulu, Hawaii 96813 |
