MenoZen VR for managing menopause symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the feasibility, acceptability, tolerability, and potential efficacy of MenoZen VR for managing menopause symptoms. Eligible participants are English-speaking women aged 45–60 with at least 28 hot flashes per week who can participate in weekly VR sessions for eight weeks. Participants must have access to a computer or smartphone and home Wi‑Fi and must not be on systemic hormone therapy or certain non-hormonal hot flash medications. The Mayo Clinic will sponsor the study with sessions conducted at Mayo Clinic in Jacksonville, Florida. The trial will assess how well participants can use the VR intervention and any changes in symptom burden over time.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Chrisandra L. Shufelt, MD, MS — Mayo Clinic
• Study coordinator: Lauren Uy
• Email: Uy.Lauren@mayo.edu
• Phone: 904-953-5337

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.