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Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550303
First Posted: October 29, 2007
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00550303     History of Changes
Other Study ID Numbers: 3115A1-1123
First Submitted: October 25, 2007
First Posted: October 29, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Estrogens
Estrogens, Conjugated (USP)
Bazedoxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents