Study Evaluating Premarin and Bazedoxifene Potential Interaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00745173
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : February 12, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Drug: Premarin

Primary Outcome Measures :
  1. Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters [ Time Frame: 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. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00745173

United States, Texas
Dr. David Carter
Austin, Texas, United States, 78752
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00745173     History of Changes
Other Study ID Numbers: 3115A1-1135
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents