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Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
This study has been completed.
First Received: October 25, 2007   Last Updated: December 18, 2007   History of Changes
Sponsor: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00550303
  Purpose

The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.


Condition Intervention Phase
Healthy
Drug: bazedoxifene/conjugated estrogens combination
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title: An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Bioavailability

Secondary Outcome Measures:
  • Safety & tolerability

Estimated Enrollment: 28
Study Start Date: October 2007
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, post menopausal women ages 45 to 70

Exclusion Criteria:

  • Male subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550303

Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Study ID Numbers: 3115A1-1123
Study First Received: October 25, 2007
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00550303     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010