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| Sponsored by: |
New York University School of Medicine |
|---|---|
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00883272 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Menopause Thrombophilia |
Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel] |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women |
Blood samples were collected in evacuated tubes (Vacutainer, Becton Dickinson) at baseline, eight weeks, and one year.
| Enrollment: | 32 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Normal Controls
25 women with CADP-CT > 66 seconds were treated with Femarelle
|
Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
a unique enzymatic isolate of the active complex in Tofu
|
|
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.
|
Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
a unique enzymatic isolate of the active complex in Tofu
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH > 40 and no menses for > 1 year.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| 251 East 33rd Street | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Lila Nachtigall, MD | New York University School of Medicine |
More Information
| Responsible Party: | NYU School of Medicine, Department of Obstetrics and Gynecology ( Rebecca Hope Jessel, MSIII ) |
| Study ID Numbers: | 03-0670-0 |
| Study First Received: | April 16, 2009 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00883272 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Menopause Thrombophilia factor V Leiden |
Estrogen Replacement Therapy Hypercoagulability Venous Thrombosis |
|
Estrogens Factor V Leiden Thrombophilia Hematologic Diseases Thrombophilia |
Venous Thrombosis Menopause Thrombosis |
|
Hematologic Diseases Thrombophilia |
