- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706225
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Bazedoxifene and Conjugated Estrogens (BZA & CE)
|
Bazedoxifene 20 mg tablet once daily for 7 days.
Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3115A1-1134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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