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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00883272

Enrollment

Registered

2009-04-17

Start date

2007-01-31

Completion date

2009-06-30

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Thrombophilia

Keywords

Menopause, Thrombophilia, factor V Leiden, Estrogen Replacement Therapy, Hypercoagulability, Venous Thrombosis

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTDT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

a unique enzymatic isolate of the active complex in Tofu

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026