A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms
A Multi-center, Randomized, Placebo-controlled Double Blind Clinical Study Assessing the Efficacy and Safety of Femarelle® in Menopausal Women With Vasomotor Syndrome
1 other identifier
interventional
200
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
5 active sites
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
First Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 12, 2011
February 1, 2010
1 year
February 4, 2010
October 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
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
Study Arms (2)
Femarelle
EXPERIMENTALWomen will receive Femarelle twice daily for 12 weeks
Placebo
PLACEBO COMPARATORWomen will take placebo capsules twice daily for 12 weeks
Interventions
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Se-cure Pharmaceuticals Ltd.lead
- Clalit Health Servicescollaborator
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bari Kaplan, Prof.
Clalit Health Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Study Start
August 1, 2011
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
October 12, 2011
Record last verified: 2010-02