A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women (Flash)

June 19, 2014 updated by: University of British Columbia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. On a scale from 1 to 10, how much are you bothered by your hot flashes?
  2. Do these hot flashes wake you up at night? Around how many times do they occur at night?
  3. 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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K3
        • Recruiting
        • Dr. Hsiang's office, 510-943 W. Broadway
        • Contact:
        • Sub-Investigator:
          • Rollin Y Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with 12 months amenorrhea
  • Experiencing more than 2 nocturnal hot flashes nightly.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Farabloc
The participants will sleep on Farabloc fabric nightly for a week.
Device: Farabloc
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.
Device: Nylon Fabric
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.
Placebo Comparator: Nylon Fabric
The participants will sleep on Nylon fabric nightly for week.
Device: Farabloc
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.
Device: Nylon Fabric
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of hot flashes
Time Frame: in the past 24 hours
The number of hot flashes subjects experienced in the past 24 hours
in the past 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of hot flash
Time Frame: In the past 24 hours
An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely)
In the past 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: York N Hsiang, MB FRCSC, University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-03052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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