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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01063725
• Other study ID #: FS1
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2010
• Last updated: October 9, 2011
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2010
• Source: Se-cure Pharmaceuticals Ltd.
• Contact: Israel Yoles, MD
• Phone: 972-547234336
• Email: yoles[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

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:
• Placebo
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily

Locations

Country	Name	City	State
Israel	Women's Health Center	Afula
Israel	Women's Health Clinic	Ashdod
Israel	Women's Health Clinic	Beit Shemesh
Israel	Women's Health Clinic	Bnei Berak
Israel	Women's Health Clinic	Rehovot

Sponsors (2)

Lead Sponsor	Collaborator
Se-cure Pharmaceuticals Ltd.	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 4 in the average Number of Hot Flashes per day		4 weeks	No
Primary	Change from Baseline to Week 4 in the average daily Severity Score of hot flashes		4 weeks	No
Primary	Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)		12 weeks	No
Primary	Change from Baseline to Week 12 in the average daily Severity Score of hot flashes		12 weeks	No
Secondary	Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12		12 weeks	No
Secondary	No serious adverse event in either groups from Week 0 (Baseline) to Week 12.		12 weeks	Yes