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

Menopause Clinical Trial

Official title:

Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883272
• Other study ID #: 03-0670-0
• Status: Completed
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Thrombophilia

Intervention

Dietary Supplement:
• DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
a unique enzymatic isolate of the active complex in Tofu

Locations

Country	Name	City	State
United States	251 East 33rd Street	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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