Study Evaluating Premarin and Bazedoxifene Potential Interaction - Full Text View

Purpose

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	Intervention	Phase
Postmenopause	Drug: Premarin	Phase I

Drug Information available for:

Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

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.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Premarin

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745173

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


United States, Texas
	Dr. David Carter
	Austin, Texas, United States, 78752

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3115A1-1135
First Received:	September 2, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00745173
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)

Healthy

Additional relevant MeSH terms:

Estrogens

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00745173