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