Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In 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 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Principal Investigator, Affiliation: Wyeth
Summary
The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated
estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated
estrogens tablets produced using a new manufacturing process
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Primary outcome: Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.
Secondary outcome: 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.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: November 2006
Ending date: November 2006
Last updated: March 12, 2007
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