Status:
COMPLETED
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
Lead Sponsor:
Pfizer
Conditions:
Primary Ovarian Insufficiency
Vaginitis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
Eligibility Criteria
Inclusion
- Japanese healthy postmenopausal women
Exclusion
- History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
- History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
- History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01436513
Start Date
October 1 2011
End Date
March 1 2012
Last Update
March 15 2012
Active Locations (1)
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1
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan