Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00396799|
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : March 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Drug: bazedoxifene/conjugated estrogens||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women|
|Study Start Date :||November 2006|
|Estimated Study Completion Date :||November 2006|
- Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.
- Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.
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): NCT00396799
|Principal Investigator:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|