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

NYU Langone Health

Status: Completed

Conditions: Thrombophilia; Menopause

Treatments: Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

Study type: Observational

Funder types: Other

Identifiers

NCT00883272

03-0670-0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

Normal Controls

Description:

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

Treatment:

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

Thrombophilic

Description:

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.

Treatment:

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