A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Phase 3
40 Years
75 Years
40 Years
75 Years
Not Enrolling
Female
Endometrial Hyperplasia, Osteoporosis
Female
Endometrial Hyperplasia, Osteoporosis
Trial Information
A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Inclusion Criteria:
- Generally healthy, postmenopausal women aged 40 - 75 years inclusive
- Intact uterus
- Last natural menstrual cycle (without exogenous hormone therapy) completed at least
12 consecutive months before screening
Exclusion Criteria:
- A history or active presence of thrombophlebitis, thrombosis or thromboembolic
disorders
- A history or active presence of cerebrovascular accident, stroke, or transient
ischemic attack
- A history or active presence of malignancy, or treatment for malignancy, within the
previous 10 years
Additional criteria applies.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
Outcome Time Frame:
one year
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3115A1-303
NCT ID:
NCT00675688
Start Date:
April 2002
Completion Date:
January 2006
Related Keywords:
- Endometrial Hyperplasia
- Osteoporosis
- Menopause
- Endometrial Hyperplasia
- Hyperplasia
- Osteoporosis
- Adenoma
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