Status:
COMPLETED
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief Summary
This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA). About 24 subjects will t...
Eligibility Criteria
Inclusion
- Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
- Postmenopausal women aged 35 to 70 years
- At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
- Women 55 years of older must have at least 12 months of amenorrhea
- Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg
Exclusion
- A history or active presence of clinically important medical disease.
- History or alcoholism or drug abuse within 1 year before study start.
- Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00367536
Start Date
August 1 2006
End Date
August 1 2006
Last Update
May 1 2015
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