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

Completed

• Conditions: Thrombophilia; Menopause
• Interventions: Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

• Registration Number: NCT00883272
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-01
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Study Completion: 2009-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Controls	DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]	25 women with CADP-CT \> 66 seconds were treated with Femarelle
Thrombophilic	DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

251 East 33rd Street; 🇺🇸 New York, New York, United States