Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood...
Date First Received: April 23, 2007
Last Updated: December 19, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 1 | Start Date: March 2007
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Intervention(s) in this Clinical Trial
- Drug: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet
Outcome Measures for this Clinical Trial
Primary Measures
- PK results
Criteria for Participation in this Clinical Trial
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).
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 35 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464789
Study ID Number: 3115A1-1120
ClinicalTrials.gov Identifier: NCT00464789
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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