Hot FlashesPhase 2NCT01281332
Mechanical Device for the Relief of Hot Flashes
A Phase 2 study testing Menopod and Inactive device in people with Hot Flashes, run by Queen's University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Menopod and Inactive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Serious medical condition:
- coronary heart disease
- stroke
- chronic renal or hepatic disease
- diabetes
- depression or other psychiatric illness
- cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.
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.
Read the detailed 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).
- Conditions
- Hot Flashes
- Being tested
- Menopod, Inactive device
- Keywords
- menopause, hot flash, quality of life
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenopodDevice
The mechanism of action of the device will not be revealed in advance.
Inactive deviceDevice
Also called The mechanism of action of the active device is disabled.
| Study group | Role | What they receive |
|---|---|---|
| Menopod device | Active comparator | Menopod® Receives: Device: Menopod |
| Sham device | Sham comparator | Inactive device. Receives: Device: Inactive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flash score and duration
Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary.
Measured: Change from baseline to end of study (week 4).
Secondary outcomes (1)
Quality of Life (QOL) and Anxiety
Subjects will complete the Hot Flash Related Daily Interference Scale once during the evaluation phase and once per week over the four week treatment phase (Carpenter 2001). This validated questionnaire assesses the impact of hot flashes on daily activities and overall QOL. They will also complete the Zung Self-Rating Anxiety Scale (Zung 1971). This validated 20-item questionnaire measures anxiety with established normal, mild to moderate, marked to severe and extreme levels.
Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage 2001 Dec;22(6):979-89.
Zung WW. A rating instrument for anxiety disorders. Psychosomatics 1971 Nov-Dec;12(6):371-9.
Measured: Change from baseline to end of study (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexander Medical Inc.
- Responsible party
- Principal investigator, Dr. Robert Reid, Queen's University
- Investigators
- Robert L. Reid, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281332
- Sponsor's protocol ID
- OBGY-208-10
- Status last verified
- Sep 2015
- First submitted
- 19 Jan 2011
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.
PubMed 11731510Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.
PubMed 11738160Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971 Nov-Dec;12(6):371-9. doi: 10.1016/S0033-3182(71)71479-0. No abstract available.
PubMed 5172928
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Mechanical Device for Relief of Menopausal Vasomotor Symptoms.
- ClinicalTrials.gov ID
- NCT01281332
- Acronym / sponsor ID
- OBGY-208-10
- Conditions
- Hot Flashes
- Keywords
- menopause, hot flash, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Alexander Medical Inc.
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menopod device | Active comparator | Device: MenopodMenopod® |
| Sham device | Sham comparator | Device: Inactive deviceInactive device. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range: 40 to 65 years
- Healthy postmenopausal woman
- natural or surgical menopause
- FSH > 30 IU/L
- Amenorrhea > 6 months prior to study
Key exclusion criteria (13 listed)
- Any therapy for hot flashes prior to or during study
- Obesity: BMI > 35
- Alcohol abuse
- Drug abuse
- Unable to use device as per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenopodThe mechanism of action of the device will not be revealed in advance. | Device | Menopod device |
| Inactive deviceAlso: The mechanism of action of the active device is disabled. | Device | Sham device |
Primary outcome
Hot flash score and duration
Time frame: 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.
1 secondary outcome
Quality of Life (QOL) and Anxiety
Time frame: Change from baseline to end of study (week 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Background: PubMed 11731510Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.
- Background: PubMed 11738160Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.
- Background: PubMed 5172928Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971 Nov-Dec;12(6):371-9. doi: 10.1016/S0033-3182(71)71479-0. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L. Reid, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Menopod and Inactive device in people with Hot Flashes, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flash score and duration (time frame: Change from baseline to end of study (week 4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.