Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women
Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women
1 other identifier
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 22, 2023
August 1, 2023
2 years
April 16, 2009
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
1 year
Study Arms (2)
Normal Controls
25 women with CADP-CT \> 66 seconds were treated with Femarelle
Thrombophilic
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.
Interventions
a unique enzymatic isolate of the active complex in Tofu
Eligibility Criteria
Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH \> 40 and no menses for \> 1 year.
You may qualify if:
- No previous exogenous estrogen exposure
- Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency
- Menopausal (see above)
You may not qualify if:
- History of bleeding or thrombotic disorder
- History of malignancy (particularly Breast Cancer)
- Diabetics
- Coronary Artery Disease
- Liver Disease
- Concurrent Anticoagulation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
251 East 33rd Street
New York, New York, 10016, United States
Related 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.
PMID: 18989235BACKGROUNDSomjen 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.
PMID: 17428655BACKGROUND
Biospecimen
Blood samples were collected in evacuated tubes (Vacutainer, Becton Dickinson) at baseline, eight weeks, and one year.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lila Nachtigall, MD
NYU Langone Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
January 1, 2007
Primary Completion
January 1, 2009
Study Completion
June 1, 2009
Last Updated
August 22, 2023
Record last verified: 2023-08