NCT07633743 · Mayo Clinic
MenoZen VR for Menopause Symptom Management
What this study is about
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical effectiveness of MenoZen VR (virtual reality) for managing menopause symptoms in women.
View original scientific description
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.
Interventions
DEVICE
MenoZen
Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
Where
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations