Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women

Study Overview
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Brief Summary
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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
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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 is estimated at 5-10%. This population has a 5-21 fold greater risk to develop VTE. Therefore, given the high thrombotic risk for the combination of hormone use and hereditary prothrombotic abnormalities these women's symptoms frequently go untreated for lack of alternative therapies. DT56a (Femarelle) is a soy derived compound that has been shown to act as a novel selective estrogen receptor modulator (SERM) in the alleviation of menopausal symptoms and prevention of postmenopausal bone loss without effecting the endometrium or the sex hormone blood profile. The research question of the current study is to assess the effect of femeralle on the coagulation system and determine if it is a reasonable and safe alternative for the treatment of menopausal symptoms in thrombophilic women.

Official Title
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Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women

Conditions
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Menopause, Thrombophilia

Intervention / Treatment
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* Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No previous exogenous estrogen exposure Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency Menopausal (see above) Exclusion Criteria: History of bleeding or thrombotic disorder History of malignancy (particularly Breast Cancer) Diabetics Coronary Artery Disease Liver Disease Concurrent Anticoagulation therapy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Controls<br>25 women with CADP-CT > 66 seconds were treated with Femarelle | Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]<br>* a unique enzymatic isolate of the active complex in Tofu<br>|
| Thrombophilic<br>Seven women in cohort of a previous study were found to have shortened closure times (CADP-CT < 61s) at time of enrollment. They all underwent genetic testing for a hypercoagulable state. | Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]<br>* a unique enzymatic isolate of the active complex in Tofu<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PFA-100 (Dade Behring, Inc.) device was used to evaluate platelet adhesion and aggregation. Clotting time (sec.) was recorded and defined as the time for blood to block a collagen membrane coated with epinephrine (CEPI) or ADP (CADP). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Thrombophilia, factor V Leiden, Estrogen Replacement Therapy, Hypercoagulability, Venous Thrombosis