Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hot flash score and duration
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •chronic renal or hepatic disease
- •depression or other psychiatric illness
研究组 & 干预措施
Menopod device
Menopod®
干预措施: Menopod (Device)
Sham device
Inactive device.
干预措施: Inactive device (Device)
结局指标
主要结局
Hot flash score and duration
时间窗: Change from baseline to end of study (week 4).
Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary.
次要结局
- Quality of Life (QOL) and Anxiety(Change from baseline to end of study (week 4).)
研究者
Dr. Robert Reid
Professor
Queen's University