NCT07633743
MenoZen VR for Menopause Symptom Management: Phase 2
Not Yet Recruiting
NAAges 45–60InterventionalTreatmentMayo ClinicInvestigator-initiated
~40 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:MenoZen
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in frequency of hot flashes
Measured over Baseline, 8 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Chrisandra L. Shufelt, MD, MS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
- Stephanie S. Faubion, MD, MBA · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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 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.
What this trial measures
- Change in frequency of hot flashesBaseline, 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 flashesBaseline, 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.