Expired Study
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Daytona Beach, Florida 32117


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.


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.


Study is Available At:


Original ID:

3115A1-1134


NCT ID:

NCT00706225


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

35 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wyeth


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:June 2008
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 21, 2010
First Received Date:June 25, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
Time Frame:3 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bazedoxifene and conjugated estrogens
Description:Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Bazedoxifene and Conjugated Estrogens (BZA & CE)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wyeth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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