Not Yet RecruitingNot Applicable

MenoZen VR for Menopause Symptom Management: Phase 2

United States40 participantsStarted 2026-07-31

Plain-language 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.

Who can participate

Age range

45 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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); * Self-reported history of acute and/or severe motion sickness; * Have had a seizure in the past year; * Concurrently enrolled in another intervention tri…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is using virtual reality — called MenoZen VR — to manage menopause symptoms like hot flashes, which is pretty different from hormone therapy or other treatments I've heard of; can you help me understand how a VR-based approach might work for hot flash frequency and severity compared to what's already available to me?
2The trial isn't recruiting yet, so there's no start date confirmed — if I'm dealing with hot flashes now, does it make sense to wait and see if I become eligible, or should we explore other treatment options in the meantime?
3Since this is listed as a Phase NA study rather than a standard Phase 1, 2, or 3 trial, what does that mean for how much is already known about whether MenoZen VR is safe and effective for managing menopause symptoms?
4The trial is specifically measuring changes in how often and how severe hot flashes are — if my main concerns go beyond hot flashes, like sleep disruption or mood changes, would a trial focused only on those two outcomes still be a good fit for my situation?
5Are there standard menopause treatments you'd recommend I try first while we wait to see if this trial opens up, or would starting another treatment now affect whether I could participate later?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in frequency of hot flashes

Timeframe: Baseline, 8 weeks

Change in severity of hot flashes

Timeframe: Baseline, 8 weeks

Trial details

NCT IDNCT07633743

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Lauren Uy

904-953-5337 Uy.Lauren@mayo.edu

View on ClinicalTrials.gov More Menopause trials