Menopause Hot FlashesNCT07824648
Thermoregulatory Physiology of Menopausal Hot Flashes
A study testing Intervention C (Targeted skin cooling), Intervention B (Ambient cooling) and Intervention A (Room temperature) in people with Menopause Hot Flashes, run by SRI International at 1 site in United States.
Trial summary
This study is evaluating the effects of cooling on menopausal hot flashes in midlife women. Precise targeted cooling is provided to areas of the skin when a hot flash occurs. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause Hot Flashes
- What is being tested?
- Intervention C (Targeted skin cooling), Intervention B (Ambient cooling) and Intervention A (Room temperature)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age range: 40 to 65 years and in menopausal transition or post-menopause;
- At least 8 years of education to ensure adequate reading proficiency;
- Primary language is English or Spanish.
Who cannot join
- History of medical or neurological illness or trauma that would affect the central nervous system (e.g., stroke, multiple sclerosis, epilepsy);
- Current severe medical conditions (e.g. Diabetes, cancer, cardiovascular disease, renal or hepatic disease, thyroid disorders);
- History of schizophrenia and/or bipolar disorder;
- Dependence or abuse of illicit substances in the past year;
- Current use of hormone therapy or other treatments for hot flash symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SRI International
Menlo Park, California, 94025-3453
Fiona Baker, 6508593062, fiona.baker@sri.com
About this study
This study is evaluating the effects of cooling on menopausal hot flashes in midlife women. Precise targeted cooling is provided to areas of the skin when a hot flash occurs.
- Conditions
- Menopause Hot Flashes
- Being tested
- Intervention C (Targeted skin cooling), Intervention B (Ambient cooling), Intervention A (Room temperature)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention C (Targeted skin cooling)Other
Cooling targeted to the skin during a hot flash
Intervention B (Ambient cooling)Other
Cooling of the room
Intervention A (Room temperature)Other
Control condition (room temperature)
| Study group | Role | What they receive |
|---|---|---|
| Sequence A-B-C | Experimental | Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling Receives: Other: Intervention C (Targeted skin cooling); Other: Intervention B (Ambient cooling); Other: Intervention A (Room temperature) |
| Sequence B-C-A | Experimental | Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature Receives: Other: Intervention C (Targeted skin cooling); Other: Intervention B (Ambient cooling); Other: Intervention A (Room temperature) |
| Sequence C-A-B | Experimental | Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling Receives: Other: Intervention C (Targeted skin cooling); Other: Intervention B (Ambient cooling); Other: Intervention A (Room temperature) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hot flashes
Number of hot flashes, based on sternal skin conductance measurement
Measured: Across the ~5 hour experimental period in the lab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 May 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are three temperature interventions, each participant may be exposed to during the study: room temperature, ambient cooling, targeted skin cooling
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824648
- Sponsor's protocol ID
- R21AG093284
- Other IDs
- R21AG093284
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoregulatory Physiology of Menopausal Hot Flashes
- ClinicalTrials.gov ID
- NCT07824648
- Acronym / sponsor ID
- R21AG093284
- Conditions
- Menopause Hot Flashes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Stanford University
- Study start
- 5 May 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- 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.
This study is evaluating the effects of cooling on menopausal hot flashes in midlife women. Precise targeted cooling is provided to areas of the skin when a hot flash occurs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three temperature interventions, each participant may be exposed to during the study: room temperature, ambient cooling, targeted skin cooling
| Arm | Type | Receives |
|---|---|---|
| Sequence A-B-C | Experimental | Other: Intervention C (Targeted skin cooling), Other: Intervention B (Ambient cooling), Other: Intervention A (Room temperature)Laboratory interventions are administered in the order of Room Temperature-Ambient Cooling-Targeted skin cooling |
| Sequence B-C-A | Experimental | Other: Intervention C (Targeted skin cooling), Other: Intervention B (Ambient cooling), Other: Intervention A (Room temperature)Laboratory interventions are administered in order of Ambient cooling-Targeted skin cooling-Room temperature |
| Sequence C-A-B | Experimental | Other: Intervention C (Targeted skin cooling), Other: Intervention B (Ambient cooling), Other: Intervention A (Room temperature)Laboratory interventions are administered in the order of Targeted skin cooling-Room temperature-Ambient cooling |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Age range: 40 to 65 years and in menopausal transition or post-menopause;
- At least 8 years of education to ensure adequate reading proficiency;
- Primary language is English or Spanish.
Key exclusion criteria (5 listed)
- History of medical or neurological illness or trauma that would affect the central nervous system (e.g., stroke, multiple sclerosis, epilepsy);
- Current severe medical conditions (e.g. Diabetes, cancer, cardiovascular disease, renal or hepatic disease, thyroid disorders);
- History of schizophrenia and/or bipolar disorder;
- Dependence or abuse of illicit substances in the past year;
- Current use of hormone therapy or other treatments for hot flash symptoms
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 |
|---|---|---|
| Intervention C (Targeted skin cooling)Cooling targeted to the skin during a hot flash | Other | Sequence A-B-C, Sequence B-C-A, Sequence C-A-B |
| Intervention B (Ambient cooling)Cooling of the room | Other | Sequence A-B-C, Sequence B-C-A, Sequence C-A-B |
| Intervention A (Room temperature)Control condition (room temperature) | Other | Sequence A-B-C, Sequence B-C-A, Sequence C-A-B |
Primary outcome
Number of hot flashes
Time frame: Across the ~5 hour experimental period in the lab
Number of hot flashes, based on sternal skin conductance measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention C (Targeted skin cooling), Intervention B (Ambient cooling) and Intervention A (Room temperature) in people with Menopause Hot Flashes, run by SRI International at 1 site in United States.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hot flashes (time frame: Across the ~5 hour experimental period in the lab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.