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

Primary Purpose

Menopause, Hot Flashes

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Femarelle
Placebo
Sponsored by
Se-cure Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Health CenterRecruiting
  • Women's Health ClinicRecruiting
  • Women's Health ClinicRecruiting
  • Women's Health ClinicRecruiting
  • Women's Health ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Femarelle

Placebo

Arm Description

Women will receive Femarelle twice daily for 12 weeks

Women will take placebo capsules twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Change from Baseline to Week 4 in the average Number of Hot Flashes per day
Change from Baseline to Week 4 in the average daily Severity Score of hot flashes
Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)
Change from Baseline to Week 12 in the average daily Severity Score of hot flashes

Secondary Outcome Measures

Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12
No serious adverse event in either groups from Week 0 (Baseline) to Week 12.

Full Information

First Posted
February 4, 2010
Last Updated
October 9, 2011
Sponsor
Se-cure Pharmaceuticals Ltd.
Collaborators
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT01063725
Brief Title
A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Se-cure Pharmaceuticals Ltd.
Collaborators
Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flashes
Keywords
menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femarelle
Arm Type
Experimental
Arm Description
Women will receive Femarelle twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Women will take placebo capsules twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Femarelle
Other Intervention Name(s)
Tofupill
Intervention Description
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Avicel
Intervention Description
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
Primary Outcome Measure Information:
Title
Change from Baseline to Week 4 in the average Number of Hot Flashes per day
Time Frame
4 weeks
Title
Change from Baseline to Week 4 in the average daily Severity Score of hot flashes
Time Frame
4 weeks
Title
Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)
Time Frame
12 weeks
Title
Change from Baseline to Week 12 in the average daily Severity Score of hot flashes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12
Time Frame
12 weeks
Title
No serious adverse event in either groups from Week 0 (Baseline) to Week 12.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israel Yoles, MD
Phone
972-547234336
Email
yoles@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bari Kaplan, Prof.
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shlomo Battino, MD
First Name & Middle Initial & Last Name & Degree
Shlomo Battino, MD
Facility Name
Women's Health Clinic
City
Ashdod
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel Yoles, MD
First Name & Middle Initial & Last Name & Degree
Israel Yoles, MD
Facility Name
Women's Health Clinic
City
Beit Shemesh
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amnon Bzizinski, MD
First Name & Middle Initial & Last Name & Degree
Amnon Bzizinski, MD
Facility Name
Women's Health Clinic
City
Bnei Berak
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham Ninio, MD
First Name & Middle Initial & Last Name & Degree
Abraham Ninio, MD
Facility Name
Women's Health Clinic
City
Rehovot
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyla Iloger, MD
First Name & Middle Initial & Last Name & Degree
Lyla Iloger, MD

12. IPD Sharing Statement

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

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