Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Hematology |
| Therapuetic Areas: | Hematology, Reproductive |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2007 |
| End Date: | June 2009 |
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.
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.
(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
We found this trial at
1
site
Click here to add this to my saved trials
