Study Evaluating Premarin and Bazedoxifene Potential Interaction

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00745173
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 30.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopause	Drug: Premarin	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1	Drug: Premarin

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters [3 months]

Secondary Outcome Measures

1. To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. David Carter	Austin	Texas	United States	78752

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00745173
• Other Study ID Numbers: 3115A1-1135
• First Posted: Sep 3, 2008
• Last Update Posted: Feb 12, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Feb 12, 2009