Status:
COMPLETED
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Menopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00396799
Start Date
November 1 2006
End Date
November 1 2006
Last Update
March 13 2007
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