MenopauseNCT00883272
Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women
An observational study of Menopause and Thrombophilia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Thrombophilia
- What is being tested?
- DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH > 40 and no menses for > 1 year.
Who may be able to join
- No previous exogenous estrogen exposure
- Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency
- Menopausal (see above)
Who cannot join
- History of bleeding or thrombotic disorder
- History of malignancy (particularly Breast Cancer)
- Diabetics
- Coronary Artery Disease
- Liver Disease
- Concurrent Anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women
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.
Read the 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.
- Conditions
- Menopause, Thrombophilia
- Being tested
- DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]
- Keywords
- Menopause, Thrombophilia, factor V Leiden, Estrogen Replacement Therapy, Hypercoagulability, Venous Thrombosis
- Medical subject headings
- Thrombophilia, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]Dietary supplement
a unique enzymatic isolate of the active complex in Tofu
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | 25 women with CADP-CT > 66 seconds were treated with Femarelle Receives: Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel] | |
| 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. Receives: Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lila Nachtigall, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883272
- Sponsor's protocol ID
- 03-0670-0
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2009
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18989235Somjen 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.
PubMed 17428655
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Femarelle (DT56a), a Novel SERM, Effect on the Clotting Time in Normal and Thrombophililic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00883272
- Acronym / sponsor ID
- 03-0670-0
- Conditions
- Menopause, Thrombophilia
- Keywords
- Menopause, Thrombophilia, factor V Leiden, Estrogen Replacement Therapy, Hypercoagulability, Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | – | Dietary Supplement: DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]25 women with CADP-CT > 66 seconds were treated with Femarelle |
| Thrombophilic | – | Dietary Supplement: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Peri- and postmenopausal women aged 40-67. Menopause defined as a FSH > 40 and no menses for > 1 year.
Key inclusion criteria (3 listed)
- No previous exogenous estrogen exposure
- Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency
- Menopausal (see above)
Key exclusion criteria (6 listed)
- History of bleeding or thrombotic disorder
- History of malignancy (particularly Breast Cancer)
- Diabetics
- Coronary Artery Disease
- Liver Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT56a (Femarelle) [Se-cure pharmaceuticals, Dalton, Israel]a unique enzymatic isolate of the active complex in Tofu | Dietary supplement | Normal Controls, Thrombophilic |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 18989235Flaumenhaft 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.
- Background: PubMed 17428655Somjen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lila Nachtigall, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Thrombophilia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883272, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.