Study Evaluating Premarin and Bazedoxifene Potential Interaction
NCT00745173
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Premarin and Bazedoxifene Potential Interaction | |||
Official Title ICMJE | 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. | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Postmenopause | |||
Intervention ICMJE | Drug: Premarin | |||
Study Arms ICMJE | 1
Intervention: Drug: Premarin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 35 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00745173 | |||
Other Study ID Numbers ICMJE | 3115A1-1135 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |