MenopauseFlashNCT02006238
A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
A study testing Farabloc and Nylon Fabric in people with Menopause, run by University of British Columbia at 1 site in Canada.
Trial summary
This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Farabloc and Nylon Fabric
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2014
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with 12 months amenorrhea
- Experiencing more than 2 nocturnal hot flashes nightly.
Who cannot join
- Other medical conditions associated with night sweats
- Currently on medication associated with night sweats
- Less than 2 nocturnal hot flashes per night
- Allergies to metals
- Abnormal mental status
- MRS scale rating of mild or above
- Currently on hormone replacement therapy or herbal supplements and cannot safety discontinue these for the duration of the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Dr. Hsiang's office, 510-943 W. Broadway
Vancouver, British Columbia, V5Z 1K3
York N Hsiang, MB FRCSC, 604.876.5882, york.hsiang@vch.ca
Rollin Y Yu
About this study
This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.
Read the detailed description
Fifty menopausal volunteers will be randomly assigned to two groups, one receiving Farabloc fabric containing Farabloc (experimental), and the other a similar-appearing fabric made of Nylon (placebo).
All eligible participants will be selected by the initial interview. The following information will be collected during interview process.
- Address
- Medical history
- Concomitant medication
- Allergies
Participants will be asked the following:
- On a scale from 1 to 10, how much are you bothered by your hot flashes?
- Do these hot flashes wake you up at night? Around how many times do they occur at night?
- What are you expectations about this study?
A Menopause Rating Scale questionnaire will be completed by the potential participant to assess symptoms Eligible patients from each group will initially undergo a 7 day washout period before intervention in order to eliminate any effects of hormone replacement therapies (HRT) or herbal supplements that subjects may be using prior to participation in the study. Subjects will be randomized to receive a Farabloc fabric or placebo fabric for one week. After this, the two groups will undergo a second 7 day washout period before crossing over to the other fabric. Once crossed over, participants will use the allocated fabrics for another week.
Participants will be asked not to take their usual HRT or herbal supplements for the entire experimental duration in this study in order to produce impartial, precise and reliable results.
The manufacturer will assign codes for placebo fabric or experimental Farabloc. The randomization code will be broken at the completion of the study for data analysis.
- Conditions
- Menopause
- Being tested
- Farabloc, Nylon Fabric
- Keywords
- Hot flash, Farabloc, menopausal women
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FarablocDevice
The participants will be randomly received Farabloc (experimental) for one week, followed by a 7 day washout and then crossed over to received the Nylon fabric (placebo) for one week.
Nylon FabricDevice
The participants will be randomly received Nylon fabric (placebo) for one week, followed by a 7 day washout and then crossed over to receive Farabloc (experimental) for one week.
| Study group | Role | What they receive |
|---|---|---|
| Farabloc | Experimental | The participants will sleep on Farabloc fabric nightly for a week. Receives: Device: Farabloc; Device: Nylon Fabric |
| Nylon Fabric | Placebo comparator | The participants will sleep on Nylon fabric nightly for week. Receives: Device: Farabloc; Device: Nylon Fabric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hot flashes
The number of hot flashes subjects experienced in the past 24 hours
Measured: in the past 24 hours
Secondary outcomes (1)
Severity of hot flash
An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely)
Measured: In the past 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- York N Hsiang, MB FRCSC, Principal investigator, University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006238
- Sponsor's protocol ID
- H13-03052
- Acronym
- Flash
- Status last verified
- Jun 2014
- First submitted
- 4 Dec 2013
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
- ClinicalTrials.gov ID
- NCT02006238
- Acronym / sponsor ID
- Flash / H13-03052
- Conditions
- Menopause
- Keywords
- Hot flash, Farabloc, menopausal women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Dec 2013 (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.
This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.
Detailed description
Fifty menopausal volunteers will be randomly assigned to two groups, one receiving Farabloc fabric containing Farabloc (experimental), and the other a similar-appearing fabric made of Nylon (placebo).
All eligible participants will be selected by the initial interview. The following information will be collected during interview process.
- Address
- Medical history
- Concomitant medication
- Allergies
Participants will be asked the following:
- On a scale from 1 to 10, how much are you bothered by your hot flashes?
- Do these hot flashes wake you up at night? Around how many times do they occur at night?
- What are you expectations about this study?
A Menopause Rating Scale questionnaire will be completed by the potential participant to assess symptoms Eligible patients from each group will initially undergo a 7 day washout period before intervention in order to eliminate any effects of hormone replacement therapies (HRT) or herbal supplements that subjects may be using prior to participation in the study. Subjects will be randomized to receive a Farabloc fabric or placebo fabric for one week. After this, the two groups will undergo a second 7 day washout period before crossing over to the other fabric. Once crossed over, participants will use the allocated fabrics for another week.
Participants will be asked not to take their usual HRT or herbal supplements for the entire experimental duration in this study in order to produce impartial, precise and reliable results.
The manufacturer will assign codes for placebo fabric or experimental Farabloc. The randomization code will be broken at the completion of the study for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Farabloc | Experimental | Device: Farabloc, Device: Nylon FabricThe participants will sleep on Farabloc fabric nightly for a week. |
| Nylon Fabric | Placebo comparator | Device: Farabloc, Device: Nylon FabricThe participants will sleep on Nylon fabric nightly for week. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with 12 months amenorrhea
- Experiencing more than 2 nocturnal hot flashes nightly.
Key exclusion criteria (7 listed)
- Other medical conditions associated with night sweats
- Currently on medication associated with night sweats
- Less than 2 nocturnal hot flashes per night
- Allergies to metals
- Abnormal mental status
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 |
|---|---|---|
| FarablocThe participants will be randomly received Farabloc (experimental) for one week, followed by a 7 day washout and then crossed over to received the Nylon fabric (placebo) for one week. | Device | Farabloc, Nylon Fabric |
| Nylon FabricThe participants will be randomly received Nylon fabric (placebo) for one week, followed by a 7 day washout and then crossed over to receive Farabloc (experimental) for one week. | Device | Farabloc, Nylon Fabric |
Primary outcome
Frequency of hot flashes
Time frame: in the past 24 hours
The number of hot flashes subjects experienced in the past 24 hours
1 secondary outcome
Severity of hot flash
Time frame: In the past 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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.
York N Hsiang, MB FRCSC principal investigator
University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Farabloc and Nylon Fabric in people with Menopause, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 7 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 York N Hsiang, MB FRCSC (604.876.5882, york.hsiang@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hot flashes (time frame: in the past 24 hours). 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 23 Jun 2014.