Hot Flashes, Menopause
Conditions
Keywords
menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTFemarelle
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
OTHERPlacebo
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
Sponsors
Clalit Health Services
Se-cure Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. postmenopausal women, i.e 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ 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
1. 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. 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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Israel
Contacts
Primary ContactIsrael Yoles, MD
Outcome results
None listed