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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00479778 |
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.
Condition | Intervention | Phase |
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Postmenopause |
Drug: Bazedoxifene/conjugated estrogens |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
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 |
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Study ID Numbers: | 3115A1-1121 |
Study First Received: | May 25, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00479778 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Postmenopause |
Estrogens, Conjugated (USP) Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones |
Estrogens Estrogens, Conjugated (USP) Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |