MenopauseNCT07633743
MenoZen VR for Menopause Symptom Management
A study testing MenoZen in people with Menopause, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- MenoZen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2026to 31 Jul 2028
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women currently between 45-60 years of age;
- Have moderate to severe VMS, defined as 28 or more hot flashes per week (including night sweats) and were sufficient severity to prompt them to seek therapeutic intervention;
- Are English-speaking;
- Able to participate fully in all aspects of the study;
- Have understood and signed study informed consent;
- Have access to a computer or smartphone and home Wi-Fi;
- Willing to participate in weekly VR sessions for 8 weeks.
Who cannot join
- Women receiving systemic menopause hormonal therapy (progesterone, testosterone, estrogen). Low-dose topical vaginal estrogen is okay;
- Women receiving non-hormonal therapy for the management of hot flashes (fezolinetant or elinzanetant, any SSRI/SNRI, oxybytunin, and/or gabapentin being prescribed for hot flashes, if for other reasons and still with hot flashes then okay);
- Women receiving active cognitive behavioral therapy (CBT) for hot flashes. CBT for mood symptoms is okay;
- Have a known, active, untreated clinically significant psychiatric condition (severe depression, psychosis, bipolar disorder, or severe depression);
- Have severe visual, auditory, or vestibular impairments that may interfere with VR use;
- Have a facial/head deformity that will prohibit the wearing of a VR head mounted displace (HMD);
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- Self-reported history of acute and/or severe motion sickness;
- Have had a seizure in the past year;
- Concurrently enrolled in another intervention trial for menopause symptoms;
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
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
Mayo Clinic
Jacksonville, Florida, 32224
Lauren Uy, 904-953-5337, Uy.Lauren@mayo.edu
About this study
Official title: MenoZen VR for Menopause Symptom Management: Phase 2
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women.
- Conditions
- Menopause
- Being tested
- MenoZen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenoZenDevice
Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| MenoZen | Experimental | Menopausal women will participate in weekly virtual reality sessions using the MenoZen VR program. Receives: Device: MenoZen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of hot flashes
Change in frequency of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will track the number of hot flashes experienced daily.
Measured: Baseline, 8 weeks
Change in severity of hot flashes
Change in severity of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will rate the type and severity of symptoms of each hot flash on a scale of mild, moderate, severe, and very severe.
Measured: Baseline, 8 weeks
Secondary outcomes (7)
Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score
The Menopause-specific Quality of Life (MENQOL) questionnaire evaluates how menopausal symptoms affect a woman's daily life. It consists of 29 items categorized into four domains: vasomotor symptoms, psychosocial symptoms, physical symptoms, and sexual symptoms. Participants indicate whether they have experienced each symptom in the past week and rate to what extent each symptom has troubled them on a 7-point Likert scale (0 = not at all bothered; 6 = extremely bothered). Total score ranges from 0 (asymptomatic) to 232 (extremely troublesome).
Measured: Baseline, 8 weeks
Change in Menopause Rating Scale (MRS) score
The Menopause Rating Scale (MRS) is an 11 item questionnaire that evaluates severity of menopause symptoms. Participants indicate the severity of each symptom on a 5-point Likert scale (0 = none; 4 = very severe) Total score ranges from 0 (no symptoms) to 44 (very severe symptoms).
Measured: Baseline, 8 weeks
System Usability Scale (SUS) score
The System Usability Scale is a 10 item questionnaire that evaluates user satisfaction. Participants answer questions about the VR program on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). Total score ranges from 10 to 50, with higher scores indicating a greater level of overall satisfaction.
Measured: 8 weeks
Change in Simulator Sickness Questionnaire (SSQ) score
The Simulator Sickness Questionnaire is a 16 item questionnaire assessing the severity of symptoms that may occur due to exposure to a VR environment. Participants answer questions on a 4-point Likert scale (1 = none; 4 = severe). Total score ranges from 16 to 64, with higher scores indicating more severe symptoms.
Measured: Baseline, 8 weeks
Change in PROMIS Sleep Disturbance short-form score
The PROMIS Sleep Disturbance short-form is an 8 item questionnaire that assesses perceived sleep quality and sleep-related impairment over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = very good; 5 = very poor), with higher scores indicating worse quality of sleep.
Measured: Baseline, 8 weeks
Change in PROMIS Depression short-form score
The PROMIS Depression short-form is an 8 item questionnaire that assesses perceived depression related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of depression.
Measured: Baseline, 8 weeks
Change in PROMIS Anxiety short-form score
The PROMIS Anxiety short-form is an 8 item questionnaire that assesses perceived anxiety related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of anxiety.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrisandra L. Shufelt, MD, Mayo Clinic
- Investigators
- Chrisandra L. Shufelt, MD, MS, Principal investigator, Mayo ClinicStephanie S. Faubion, MD, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633743
- Sponsor's protocol ID
- 26-002719
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MenoZen VR for Menopause Symptom Management: Phase 2
- ClinicalTrials.gov ID
- NCT07633743
- Acronym / sponsor ID
- 26-002719
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Jun 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.
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MenoZen | Experimental | Device: MenoZenMenopausal women will participate in weekly virtual reality sessions using the MenoZen VR program. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women currently between 45-60 years of age;
- Have moderate to severe VMS, defined as 28 or more hot flashes per week (including night sweats) and were sufficient severity to prompt them to seek therapeutic intervention;
- Are English-speaking;
- Able to participate fully in all aspects of the study;
- Have understood and signed study informed consent;
Key exclusion criteria (10 listed)
- Women receiving systemic menopause hormonal therapy (progesterone, testosterone, estrogen). Low-dose topical vaginal estrogen is okay;
- Women receiving non-hormonal therapy for the management of hot flashes (fezolinetant or elinzanetant, any SSRI/SNRI, oxybytunin, and/or gabapentin being prescribed for hot flashes, if for other reasons and still with hot flashes then okay);
- Women receiving active cognitive behavioral therapy (CBT) for hot flashes. CBT for mood symptoms is okay;
- Have a known, active, untreated clinically significant psychiatric condition (severe depression, psychosis, bipolar disorder, or severe depression);
- Have severe visual, auditory, or vestibular impairments that may interfere with VR use;
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 |
|---|---|---|
| MenoZenParticipants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks. | Device | MenoZen |
Primary outcome
Change in frequency of hot flashes
Time frame: Baseline, 8 weeks
Change in frequency of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will track the number of hot flashes experienced daily.
Change in severity of hot flashes
Time frame: Baseline, 8 weeks
Change in severity of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will rate the type and severity of symptoms of each hot flash on a scale of mild, moderate, severe, and very severe.
7 secondary outcomes
Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score
Time frame: Baseline, 8 weeks
Change in Menopause Rating Scale (MRS) score
Time frame: Baseline, 8 weeks
System Usability Scale (SUS) score
Time frame: 8 weeks
Change in Simulator Sickness Questionnaire (SSQ) score
Time frame: Baseline, 8 weeks
Change in PROMIS Sleep Disturbance short-form score
Time frame: Baseline, 8 weeks
Change in PROMIS Depression short-form score
Time frame: Baseline, 8 weeks
Change in PROMIS Anxiety short-form score
Time frame: Baseline, 8 weeks
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Chrisandra L. Shufelt, MD, MS principal investigator
Mayo Clinic
Stephanie S. Faubion, MD, MBA principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MenoZen in people with Menopause, run by Mayo Clinic 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 7 inclusion and 10 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 24 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?
Contact Lauren Uy (904-953-5337, Uy.Lauren@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of hot flashes (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. 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 24 Sep 2026.