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Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00550303
First received: October 25, 2007
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on May 23, 2013