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

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