Clinical trial NCT00883272: Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women
Official title: Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Thrombophilia
Keywords: Menopause
Thrombophilia
factor V Leiden
Estrogen Replacement Therapy
Hypercoagulability
Venous Thrombosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 32
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: 251 East 33rd Street
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lila Nachtigall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.