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

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.

Study Overview

• Status: Unknown
• Conditions: Hot Flashes; Menopause
• Intervention / Treatment: Dietary supplement: Femarelle; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Women's Health Center
    • Contact: Shlomo Battino, MD
    • Principal Investigator: Shlomo Battino, MD
  • Ashdod, Israel
    • Recruiting
    • Women's health clinic
    • Contact: Israel Yoles, MD
    • Principal Investigator: Israel Yoles, MD
  • Beit Shemesh, Israel
    • Recruiting
    • Women's health clinic
    • Contact: Amnon Bzizinski, MD
    • Principal Investigator: Amnon Bzizinski, MD
  • Bnei Berak, Israel
    • Recruiting
    • Women's health clinic
    • Contact: Abraham Ninio, MD
    • Principal Investigator: Abraham Ninio, MD
  • Rehovot, Israel
    • Recruiting
    • Women's health clinic
    • Contact: Lyla Iloger, MD
    • Principal Investigator: Lyla Iloger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Se-cure Pharmaceuticals Ltd.
• Collaborators: Clalit Health Services
• Investigators: Principal Investigator: Bari Kaplan, Prof., Clalit health services

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 4, 2010
• First Posted (Estimate): February 5, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 9, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: vasomotor symptoms; menopause; hot flashes; SERM; femarelle; soy extract
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: FS1