Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menopause
Intervention: Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: PK results
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Additional Information
Starting date: March 2007
Ending date: May 2007
Last updated: December 19, 2007
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