A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
Flash
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 23, 2014
June 1, 2014
4 months
December 4, 2013
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of hot flashes
The number of hot flashes subjects experienced in the past 24 hours
in the past 24 hours
Secondary Outcomes (1)
Severity of hot flash
In the past 24 hours
Study Arms (2)
Farabloc
EXPERIMENTALThe participants will sleep on Farabloc fabric nightly for a week.
Nylon Fabric
PLACEBO COMPARATORThe participants will sleep on Nylon fabric nightly for week.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Women with 12 months amenorrhea
- Experiencing more than 2 nocturnal hot flashes nightly.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Hsiang's office, 510-943 W. Broadway
Vancouver, British Columbia, V5Z 1K3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
York N Hsiang, MB FRCSC
University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 10, 2013
Study Start
February 1, 2014
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
June 23, 2014
Record last verified: 2014-06