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Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women

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.
ClinicalTrials.gov Identifier: NCT00706225
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : September 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis.

PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.


Condition or disease Intervention/treatment Phase
Postmenopause Drug: Bazedoxifene and conjugated estrogens Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label, Single/Multiple Dose, Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Bazedoxifene On Conjugated Estrogens (CE) In Healthy Postmenopausal Women
Study Start Date : June 2008
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Bazedoxifene and Conjugated Estrogens (BZA & CE)
Drug: Bazedoxifene and conjugated estrogens
Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women. [ Time Frame: 3 months ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
  • Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
  • Must not have a history of drug or alcohol abuse within 1 year and do not 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)
  • Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
  • Must not donate any other plasma or blood during the total study.
  • All test results and study criteria for the study are met.

Exclusion Criteria:

  • Only healthy postmenopausal women are eligible.
  • Health assessed by clinical chemistry laboratory results and physical exam.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00706225


Locations
United States, Florida
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00706225     History of Changes
Other Study ID Numbers: 3115A1-1134
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010

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