Postmenopause
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women. Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.
Interventions
DRUGPremarin
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive. * Blood hormone levels must be consistent with a postmenopausal state (for specified subjects). * They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements
Exclusion criteria
* A subject will be excluded from participation if they : * Have participated in a clinical drug study within 30 days prior to study medication administration; * Have a history of drug or alcohol abuse within 1 year or 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); * Donate any other plasma or blood during the total study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population. | 3 months |
Countries
United States
Outcome results
None listed