Postmenopause Clinical Trial
Official title:
An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 70 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dr. David Carter | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters | 3 months | No | |
Secondary | To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population. | 3 months | Yes |
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