Status:
COMPLETED
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief Summary
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis. PREMARIN® (conjugat...
Eligibility Criteria
Inclusion
- Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
- Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
- Must not have a history of drug or alcohol abuse within 1 year and do not consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine)
- Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
- Must not donate any other plasma or blood during the total study.
- All test results and study criteria for the study are met.
Exclusion
- Only healthy postmenopausal women are eligible.
- Health assessed by clinical chemistry laboratory results and physical exam.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00706225
Start Date
June 1 2008
End Date
July 1 2008
Last Update
September 23 2010
Active Locations (1)
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1
Daytona Beach, Florida, United States, 32117