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

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ClinicalTrials.gov Identifier: NCT00883272
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment
Menopause Thrombophilia Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]

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 Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women
Study Start Date : January 2007
Primary Completion Date : January 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Normal Controls
25 women with CADP-CT > 66 seconds were treated with Femarelle
Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
a unique enzymatic isolate of the active complex in Tofu
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.
Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
a unique enzymatic isolate of the active complex in Tofu

Primary Outcome Measures :
  1. 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). [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Blood samples were collected in evacuated tubes (Vacutainer, Becton Dickinson) at baseline, eight weeks, and one year.

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH > 40 and no menses for > 1 year.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883272

United States, New York
251 East 33rd Street
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Lila Nachtigall, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00883272     History of Changes
Other Study ID Numbers: 03-0670-0
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by New York University School of Medicine:
factor V Leiden
Estrogen Replacement Therapy
Venous Thrombosis

Additional relevant MeSH terms:
Hematologic Diseases