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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Se-cure Pharmaceuticals Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Se-cure Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01063725
First received: February 4, 2010
Last updated: October 9, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention
Menopause
Hot Flashes
Dietary Supplement: Femarelle
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by Se-cure Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Change from Baseline to Week 4 in the average Number of Hot Flashes per day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 4 in the average daily Severity Score of hot flashes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 12 in the average daily Severity Score of hot flashes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • No serious adverse event in either groups from Week 0 (Baseline) to Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Avicel

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063725

Contacts
Contact: Israel Yoles, MD 972-547234336 yoles@netvision.net.il

Locations
Israel
Women's Health Center Recruiting
Afula, Israel
Contact: Shlomo Battino, MD         
Principal Investigator: Shlomo Battino, MD         
Women's Health Clinic Recruiting
Ashdod, Israel
Contact: Israel Yoles, MD         
Principal Investigator: Israel Yoles, MD         
Women's Health Clinic Recruiting
Beit Shemesh, Israel
Contact: Amnon Bzizinski, MD         
Principal Investigator: Amnon Bzizinski, MD         
Women's Health Clinic Recruiting
Bnei Berak, Israel
Contact: Abraham Ninio, MD         
Principal Investigator: Abraham Ninio, MD         
Women's Health Clinic Recruiting
Rehovot, Israel
Contact: Lyla Iloger, MD         
Principal Investigator: Lyla Iloger, MD         
Sponsors and Collaborators
Se-cure Pharmaceuticals Ltd.
Clalit Health Services
Investigators
Principal Investigator: Bari Kaplan, Prof. Clalit Health Services
  More Information

No publications provided

Responsible Party: Se-cure Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01063725     History of Changes
Other Study ID Numbers: FS1
Study First Received: February 4, 2010
Last Updated: October 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Se-cure Pharmaceuticals Ltd.:
menopause
hot flashes
vasomotor symptoms
femarelle
soy extract
SERM

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014