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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00706225

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

30.4

Patients Per Site Per Month

Study Details

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

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 :

Jun 1, 2008

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

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.

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

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. [3 months]

Secondary Outcome Measures

To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women. [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:

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

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00706225

Other Study ID Numbers:

3115A1-1134

First Posted:

Jun 27, 2008

Last Update Posted:

Sep 23, 2010

Last Verified:

Sep 1, 2010

Additional relevant MeSH terms:

Bazedoxifene

Estrogens

Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Sep 23, 2010