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
  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:


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
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, see Learn About Clinical Studies.

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 July 23, 2014