A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms
NCT ID: NCT01063725
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2011-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Femarelle
Women will receive Femarelle twice daily for 12 weeks
Femarelle
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
Placebo
Women will take placebo capsules twice daily for 12 weeks
Placebo
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
Interventions
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Femarelle
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
Placebo
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. More than 7 hot flushes per day or over 50 per week at baseline.
3. Women should have documentation of a negative screening mammogram (obtained at screening or within 1 year of study enrolment.
4. Normal pelvic and breast exams by investigator prior to enrolment.
5. All subjects who have a uterus should have endometrial thickness of less than 5mm in vaginal sonogram exam at randomization.
6. Informed consent to participate in the study.
Exclusion Criteria
2. Use of SSRIs, St. John's Wort, within a minimum of 8 weeks prior to pre-study screening period.
3. Any clinically unstable or uncontrolled renal, hepatic, endocrine, respiratory, hematological, neurological, cardiovascular or cerebrovascular disease that would put the subject at safety risk or mask measure of efficacy
4. Evidence or history of vascular disease (such as ischemic heart disease), Cerebrovascular accident (such as stroke or transient ischemic attack) or deep vein thrombosis (blood clots), or thromboembolic disorders.
5. Personal history of breast cancer
6. Abnormal clinically relevant vaginal bleeding
7. Any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening
8. Abnormal, clinically significant results of mammography
9. Malignancy with the exception of BCC of the skin
10. Known hypersensitivity to gluten, soybeans, soy protein, estrogens and/or progestins
11. History of severe recurrent depression, or severe psychiatric disturbance. Untreated or uncontrolled high blood pressure (hypertension)
12. Participation in a clinical trial within 30 days prior to screening Known substance abuse (alcohol or drug)
13. Unable to comply with study protocol
40 Years
65 Years
FEMALE
No
Sponsors
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Clalit Health Services
OTHER
Se-cure Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bari Kaplan, Prof.
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Locations
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Women's Health Center
Afula, , Israel
Women's Health Clinic
Ashdod, , Israel
Women's Health Clinic
Bet Shemesh, , Israel
Women's Health Clinic
Bnei Brak, , Israel
Women's Health Clinic
Rehovot, , Israel
Countries
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Central Contacts
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Facility Contacts
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Shlomo Battino, MD
Role: primary
Israel Yoles, MD
Role: primary
Amnon Bzizinski, MD
Role: primary
Abraham Ninio, MD
Role: primary
Lyla Iloger, MD
Role: primary
Other Identifiers
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FS1
Identifier Type: -
Identifier Source: org_study_id