A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot flushes and quality of life in menopausal women. Our hypotheses are that compared to placebo, Femarelle reduces the daily number of hot flushes and their severity and also improves the quality of life as measured by validated dairies and questionnaires.

Detailed Description
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Symptomatic menopausal women will be divided to treatment with Femarelle or placebo for 12 weeks after two weeks of baseline record. Hot flashes daily diary will be recorded daily and a quality of life questionnaire will be filled at the beginning and at completion of the study.

Official Title
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A Multi-center, Randomized, Placebo-controlled Double Blind Clinical Study Assessing the Efficacy and Safety of Femarelle® in Menopausal Women With Vasomotor Syndrome

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Dietary Supplement: Femarelle
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal women, i.e 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ More than 7 hot flushes per day or over 50 per week at baseline. Women should have documentation of a negative screening mammogram (obtained at screening or within 1 year of study enrolment. Normal pelvic and breast exams by investigator prior to enrolment. All subjects who have a uterus should have endometrial thickness of less than 5mm in vaginal sonogram exam at randomization. Informed consent to participate in the study. Exclusion Criteria: Use of any medication or supplements for menopausal symptoms, such as estrogen/progestin containing drug products, Isoflavons, phytoestrogens and SERM within a minimum of 8 weeks prior to pre-study screening period. Use of SSRIs, St. John's Wort, within a minimum of 8 weeks prior to pre-study screening period. 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 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. Personal history of breast cancer Abnormal clinically relevant vaginal bleeding Any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening Abnormal, clinically significant results of mammography Malignancy with the exception of BCC of the skin Known hypersensitivity to gluten, soybeans, soy protein, estrogens and/or progestins History of severe recurrent depression, or severe psychiatric disturbance. Untreated or uncontrolled high blood pressure (hypertension) Participation in a clinical trial within 30 days prior to screening Known substance abuse (alcohol or drug) Unable to comply with study protocol

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femarelle<br>Women will receive Femarelle twice daily for 12 weeks | Dietary Supplement: Femarelle<br>* A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily<br>* Other names: Tofupill;|
| Placebo Comparator: Placebo<br>Women will take placebo capsules twice daily for 12 weeks | Other: Placebo<br>* Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily<br>* Other names: Avicel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 4 in the average Number of Hot Flashes per day |  | 4 weeks | 
| Change from Baseline to Week 4 in the average daily Severity Score of hot flashes |  | 4 weeks | 
| Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week) |  | 12 weeks | 
| Change from Baseline to Week 12 in the average daily Severity Score of hot flashes |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12 |  | 12 weeks | 
| No serious adverse event in either groups from Week 0 (Baseline) to Week 12. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM