Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Controls | 25 women with CADP-CT > 66 seconds were treated with Femarelle |
| |
| Thrombophilic | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel] | Dietary Supplement | a unique enzymatic isolate of the active complex in Tofu |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH > 40 and no menses for > 1 year.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lila Nachtigall, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 251 East 33rd Street | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18989235 | Background | Flaumenhaft R, Nachtigall M, Lowenstein J, Nachtigall L, Nachtigall R, Nachtigall L. Association of oral but not transdermal estrogen therapy with enhanced platelet reactivity in a subset of postmenopausal women. Menopause. 2009 Mar-Apr;16(2):407-12. doi: 10.1097/gme.0b013e3181833886. | |
| 17428655 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019851 | Thrombophilia |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C478341 | DT56a |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples were collected in evacuated tubes (Vacutainer, Becton Dickinson) at baseline, eight weeks, and one year.
| Somjen D, Katzburg S, Knoll E, Hendel D, Stern N, Kaye AM, Yoles I. DT56a (Femarelle): a natural selective estrogen receptor modulator (SERM). J Steroid Biochem Mol Biol. 2007 May;104(3-5):252-8. doi: 10.1016/j.jsbmb.2007.03.004. Epub 2007 Mar 14. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |