MenopauseNCT01063725
A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms
A study testing Femarelle in people with Menopause and Hot Flashes, run by Se-cure Pharmaceuticals Ltd. at 5 sites in Israel.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Femarelle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesIsrael
- Study dates
- Aug 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites, 5 recruiting
- Recruiting
Women's Health Center
Afula
Shlomo Battino, MD
Shlomo Battino, MD
- Recruiting
Women's Health Clinic
Ashdod
Israel Yoles, MD
Israel Yoles, MD
- Recruiting
Women's Health Clinic
Bet Shemesh
Amnon Bzizinski, MD
Amnon Bzizinski, MD
- Recruiting
Women's Health Clinic
Bnei Brak
Abraham Ninio, MD
Abraham Ninio, MD
- Recruiting
Women's Health Clinic
Rehovot
Lyla Iloger, MD
Lyla Iloger, MD
About this study
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
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.
Read the 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.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Femarelle, Placebo
- Keywords
- menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemarelleDietary supplement
Also called Tofupill
A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily
PlaceboOther
Also called Avicel
Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| Femarelle | Experimental | Women will receive Femarelle twice daily for 12 weeks Receives: Dietary Supplement: Femarelle |
| Placebo | Placebo comparator | Women will take placebo capsules twice daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 in the average Number of Hot Flashes per day
Measured: 4 weeks
Change from Baseline to Week 4 in the average daily Severity Score of hot flashes
Measured: 4 weeks
Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)
Measured: 12 weeks
Change from Baseline to Week 12 in the average daily Severity Score of hot flashes
Measured: 12 weeks
Secondary outcomes (2)
Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12
Measured: 12 weeks
No serious adverse event in either groups from Week 0 (Baseline) to Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Se-cure Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Bari Kaplan, Prof., Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063725
- Sponsor's protocol ID
- FS1
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063725
- Acronym / sponsor ID
- FS1
- Conditions
- Menopause, Hot Flashes
- Keywords
- menopause, hot flashes, vasomotor symptoms, femarelle, soy extract, SERM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Se-cure Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femarelle | Experimental | Dietary Supplement: FemarelleWomen will receive Femarelle twice daily for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboWomen will take placebo capsules twice daily for 12 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemarelleAlso: TofupillA soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily | Dietary supplement | Femarelle |
| PlaceboAlso: AvicelCapsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily | Other | Placebo |
Primary outcome
Change from Baseline to Week 4 in the average Number of Hot Flashes per day
Time frame: 4 weeks
Change from Baseline to Week 4 in the average daily Severity Score of hot flashes
Time frame: 4 weeks
Change from Baseline to Week 12 in the average Number of Hot Flashes per day (averaged over the week)
Time frame: 12 weeks
Change from Baseline to Week 12 in the average daily Severity Score of hot flashes
Time frame: 12 weeks
2 secondary outcomes
Change in average Number of Hot Flashes per day from Baseline to Week 4 and Week 12
Time frame: 12 weeks
No serious adverse event in either groups from Week 0 (Baseline) to Week 12.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bari Kaplan, Prof. principal investigator
Clalit Health Services
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femarelle in people with Menopause and Hot Flashes, run by Se-cure Pharmaceuticals Ltd. at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Israel Yoles, MD (972-547234336, yoles@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 4 in the average Number of Hot Flashes per day (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.