Clinical trial NCT01063725: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Hot Flashes
Keywords: menopause
hot flashes
vasomotor symptoms
femarelle
soy extract
SERM
Lead sponsor: Se-cure Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2010-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline to Week 4 in the average Number of Hot Flashes per day
timeFrame: 4 weeks
measure: Change from Baseline to Week 4 in the average daily Severity Score of hot flashes
timeFrame: 4 weeks
measure: Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in the average daily Severity Score of hot flashes
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12
timeFrame: 12 weeks
measure: No serious adverse event in either groups from Week 0 (Baseline) to Week 12.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Women's Health Center
city: Ashdod
country: Israel
facility: Women's Health Clinic
city: Beit Shemesh
country: Israel
facility: Women's Health Clinic
city: Bnei Berak
country: Israel
facility: Women's Health Clinic
city: Rehovot
country: Israel
facility: Women's Health Clinic
Study officials:
affiliation: Clalit Health Services
name: Bari Kaplan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: