Menopause
Conditions
Brief 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
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed