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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Menopause Thrombophilia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Controls

25 women with CADP-CT \> 66 seconds were treated with Femarelle

DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

Intervention Type DIETARY_SUPPLEMENT

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.

DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

Intervention Type DIETARY_SUPPLEMENT

a unique enzymatic isolate of the active complex in Tofu

Interventions

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DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

a unique enzymatic isolate of the active complex in Tofu

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes