Study Evaluating Premarin and Bazedoxifene Potential Interaction

Completed · Phase 1

Conditions studied: Postmenopause

In brief

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.

Key facts

Study ID

NCT00745173

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

30

Starts

2008-09-01

Expected to finish

2008-10-01

Last updated by the study team

2009-02-12

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dr. David Carter — Austin, Texas, United States

Full record on ClinicalTrials.gov

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