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Mechanical Device for the Relief of Hot Flashes

This study has been withdrawn prior to enrollment.
(Technical problems precluded making equipment available for research study.)
Sponsor:
Collaborator:
Menopod Corp.
Information provided by (Responsible Party):
Robert Reid, Queen's University
ClinicalTrials.gov Identifier:
NCT01281332
First received: January 19, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

Hypothesis: A mechanical cooling device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition.

Women have reported that sudden application of a cooling device (e.g. a cold soft drink can) to the back of the neck at the onset of a flash can afford immediate relief. The impracticality of keeping a drink can cold all the time and carrying it at around at work has led to the development of a novel portable cooling unit (a mini-refrigeration unit called the Menopod®) that can rapidly lower the temperature of metal plates on its surface to 10 degrees C with the click of a button. This pilot study will evaluate the effectiveness of this unit.


Condition Intervention Phase
Hot Flashes
 Device: Menopod cooling device
Device: Inactive device
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Hot flash score and duration [ Time Frame: Change from baseline to end of study (week 4). ] [ Designated as safety issue: No ]
    Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary.


Secondary Outcome Measures:
  • Quality of Life over one day [ Time Frame: Change from baseline to end of study (week 4). ] [ Designated as safety issue: No ]
    Using the Menopause Rating Scale (Heineman 2004, Dinger 2006)


Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Menopod cooling device
Menopod®
 Device: Menopod cooling device
When activated cooling maintained for one minute.
Sham Comparator: Sham device
Inactive device that emits a vibration when activated.
 Device: Inactive device
When activated device emits a vibration without cooling.

Detailed Description:

This is a pilot study to test logistics and gather information. We will randomly allocate 40 subjects to receive either the active Menopod cooling device (n=20) or a sham device with the cooling mechanism disabled (n=20).

We will recruit menopausal women with moderate to severe hot flashes (as defined by FDA standards this means a minimum of 7 per day).

The two primary outcome parameters are the hot flash score which is the product of frequency x intensity (Sloan 2001), and the average duration (in minutes) of hot flash episodes over the course of one day. These outcomes will be self-recorded by subjects in a diary designed by our research team on five separate days throughout the course of the study, once during the evaluation phase and once per week over the four week treatment phase. The two summary measures will be the changes from baseline to the last record collected for hot flash scores and average durations. Delta values (assessment phase minus fourth treatment period) will be compared between the two treatment groups (active versus sham device) using t tests (IBM SPSS Statistics version 19).

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy postmenopausal woman
  • natural or surgical menopause
  • FSH > 30 IU/L
  • Amenorrhea > 6 months prior to study
  • Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase

Exclusion Criteria:

  • Any therapy for hot flashes prior to or during study
  • Obesity: BMI > 35
  • Alcohol abuse
  • Drug abuse
  • Unable to use device as per protocol
  • Unable to complete required documentation
  • Serious medical condition:
  • coronary heart disease
  • stroke
  • chronic renal or hepatic disease
  • diabetes
  • depression or other psychiatric illness
  • cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281332

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2N6
Sponsors and Collaborators
Queen's University
Menopod Corp.
Investigators
Principal Investigator: Robert L. Reid, MD Queen's University
  More Information

Publications:

Responsible Party: Robert Reid, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01281332     History of Changes
Other Study ID Numbers: OBGY-208-10
Study First Received: January 19, 2011
Last Updated: February 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
menopause
hot flash
quality of life

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013