Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT00464789 |
Recruitment Status
:
Completed
First Posted
: April 24, 2007
Last Update Posted
: December 28, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menopause | Drug: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Bazedoxifene/Conjugated Estrogens (Premarin Current Process) And Bazedoxifene/Conjugated Estrogens (Premarin New Process) In Healthy Postmenopausal Women |
Study Start Date : | March 2007 |
Actual Study Completion Date : | May 2007 |

- PK results

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Ages Eligible for Study: | 35 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Postmenopausal women aged 35 to 70 years
- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg
- Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
- Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
- History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).

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): NCT00464789
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00464789 History of Changes |
Other Study ID Numbers: |
3115A1-1120 |
First Posted: | April 24, 2007 Key Record Dates |
Last Update Posted: | December 28, 2007 |
Last Verified: | December 2007 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Postmenopausal |
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 |