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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menopause | Drug: bazedoxifene/conjugated estrogens | 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-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 |
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.

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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
- Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
- At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
- Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.
Exclusion Criteria
- Women with amenorrhea starting after 54 years of age.
- A history or active presence of clinically important medical diseases.
- Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

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 |
ClinicalTrials.gov Identifier: | NCT00396799 History of Changes |
Other Study ID Numbers: |
3115A1-114 |
First Posted: | November 8, 2006 Key Record Dates |
Last Update Posted: | March 13, 2007 |
Last Verified: | March 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 |