Study Evaluating Potential Drug Interaction of Bazedoxifene & Premarin in Healthy Postmenopausal Women - Full Text View

Purpose

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	Intervention	Phase
Postmenopause	Drug: BZA & CE	Phase I

Drug Information available for:

Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, 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 Bazedoxifene On Conjugated Estrogens (CE) 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:

safety of CE & BZA [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental BZA & CE	Drug: BZA & CE

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706225

Locations


United States, Florida

	Daytona Beach, Florida, United States, 32117

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:	3115A1-1134
First Received:	June 25, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00706225
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)

Healthy

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00706225