Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
NCT ID: NCT00472004
Last Updated: 2010-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
204 participants
INTERVENTIONAL
2006-02-28
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
2
Tibolone 2.5 mg 1 daily, 1 year duration
Tibolone (Livial)
Tibolone 2.5 mg 1 daily, 1 year duration
Interventions
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17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)
17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration
Tibolone (Livial)
Tibolone 2.5 mg 1 daily, 1 year duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Endometrial hyperplasia
* Any malignancy with the exception of a history of basal cell carcinoma of the skin
45 Years
55 Years
FEMALE
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2481004
Identifier Type: -
Identifier Source: secondary_id
0753T-101800
Identifier Type: -
Identifier Source: org_study_id