The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days...
Date First Received: May 25, 2007
Last Updated: December 19, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 1 | Start Date: April 2007
Overall Status: Completed
Estimated Enrollment: 72
Brief Summary
Official Title: “An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women”
Condition Keyword(s):
Intervention(s):
The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Bazedoxifene/conjugated estrogens
Outcome Measures for this Clinical Trial
Primary Measures
- Pharmacokinetic analyses.
Criteria for Participation in this Clinical Trial
- Postmenopausal women, aged 40 to 65 years.
- Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
- A history or active presence of clinically relevant important medical disease.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00479778
Study ID Number: 3115A1-1121
ClinicalTrials.gov Identifier: NCT00479778
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
