Status:
COMPLETED
Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women
Lead Sponsor:
NYU Langone Health
Conditions:
Menopause
Thrombophilia
Eligibility:
FEMALE
40+ years
Brief Summary
The purpose of this study is to determine if Femeralle (DT56a) has an effect on the coagulation system, measured by platelet adhesion and aggregation, of normal and thrombophilic postmenopausal women.
Detailed Description
Women using hormone therapy (HT) are at an increased relative risk of venous thromboembolism (VTE). The frequency of inherited Factor V Leiden and other risk factors for VTE in the general population ...
Eligibility Criteria
Inclusion
- No previous exogenous estrogen exposure
- Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency
- Menopausal (see above)
Exclusion
- History of bleeding or thrombotic disorder
- History of malignancy (particularly Breast Cancer)
- Diabetics
- Coronary Artery Disease
- Liver Disease
- Concurrent Anticoagulation therapy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00883272
Start Date
January 1 2007
End Date
June 1 2009
Last Update
August 22 2023
Active Locations (1)
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1
251 East 33rd Street
New York, New York, United States, 10016