Status:
COMPLETED
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Vasomotor Symptoms
Eligibility:
FEMALE
45-55 years
Phase:
PHASE4
Brief Summary
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
Eligibility Criteria
Inclusion
- Generally healthy postmenopausal women
- Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
- At least 1 year of natural occurring amenorrhea
Exclusion
- Known or suspected estrogen-dependent neoplasia
- Endometrial hyperplasia
- Any malignancy with the exception of a history of basal cell carcinoma of the skin
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00472004
Start Date
February 1 2006
End Date
December 1 2009
Last Update
October 29 2010
Active Locations (1)
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1
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico, 01090