Mechanical Device for the Relief of Hot Flashes

Queen's University

Status and phase: Completed; Phase 2

Conditions: Hot Flashes

Treatments: Device: Menopod; Device: Inactive device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01281332

OBGY-208-10

Details and patient eligibility

About

Hypothesis: A mechanical 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. This pilot study will evaluate the effectiveness of this unit.

The mechanism of action of the device will not be revealed in advance.

Full description

This is a pilot study to test logistics and gather information for planning the definite trial. We will randomly allocate 40 subjects to receive either the active Menopod device (n=20) or a sham device with the 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 21).

Enrollment: 40 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age range: 40 to 65 years
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Menopod device

Active Comparator group

Description:

Menopod®

Treatment:

Device: Menopod

Sham device

Sham Comparator group

Description:

Inactive device.

Treatment:

Device: Inactive device