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”

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 Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: BZA & CE

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • BZA & CE

Primary Measures

• Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• safety of CE & BZA
  • Time Frame: 3 months
    Safety Issue?: Yes

• 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00706225

Study ID Number: 3115A1-1134

ClinicalTrials.gov Identifier: NCT00706225

Health Authority: United States: Food and Drug Administration