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Clinical Trials/NCT07633743
NCT07633743Not yet recruitingNot Applicable

MenoZen VR for Menopause Symptom Management: Phase 2

Mayo Clinic1 site in 1 country40 target enrollmentStarted: July 31, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chrisandra L. Shufelt, MD

Principal Investigator

Mayo Clinic

Study Sites (1)

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