MenoZen VR for Menopause Symptom Management: Phase 2

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 Overview

• Status: Not yet recruiting
• Conditions: Menopause
• Intervention / Treatment: Device: MenoZen

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Uy; Phone Number: 904-953-5337; Email: Uy.Lauren@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
      • Contact: Lauren Uy; Phone Number: 904-953-5337; Email: Uy.Lauren@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenoZen; Menopausal women will participate in weekly virtual reality sessions using the MenoZen VR program.	Device: MenoZen; Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of hot flashes	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.	Baseline, 8 weeks
Change in severity of hot flashes	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.	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score	The Menopause-specific Quality of Life (MENQOL) questionnaire evaluates how menopausal symptoms affect a woman's daily life. It consists of 29 items categorized into four domains: vasomotor symptoms, psychosocial symptoms, physical symptoms, and sexual symptoms. Participants indicate whether they have experienced each symptom in the past week and rate to what extent each symptom has troubled them on a 7-point Likert scale (0 = not at all bothered; 6 = extremely bothered). Total score ranges from 0 (asymptomatic) to 232 (extremely troublesome).	Baseline, 8 weeks
Change in Menopause Rating Scale (MRS) score	The Menopause Rating Scale (MRS) is an 11 item questionnaire that evaluates severity of menopause symptoms. Participants indicate the severity of each symptom on a 5-point Likert scale (0 = none; 4 = very severe) Total score ranges from 0 (no symptoms) to 44 (very severe symptoms).	Baseline, 8 weeks
System Usability Scale (SUS) score	The System Usability Scale is a 10 item questionnaire that evaluates user satisfaction. Participants answer questions about the VR program on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). Total score ranges from 10 to 50, with higher scores indicating a greater level of overall satisfaction.	8 weeks
Change in Simulator Sickness Questionnaire (SSQ) score	The Simulator Sickness Questionnaire is a 16 item questionnaire assessing the severity of symptoms that may occur due to exposure to a VR environment. Participants answer questions on a 4-point Likert scale (1 = none; 4 = severe). Total score ranges from 16 to 64, with higher scores indicating more severe symptoms.	Baseline, 8 weeks
Change in PROMIS Sleep Disturbance short-form score	The PROMIS Sleep Disturbance short-form is an 8 item questionnaire that assesses perceived sleep quality and sleep-related impairment over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = very good; 5 = very poor), with higher scores indicating worse quality of sleep.	Baseline, 8 weeks
Change in PROMIS Depression short-form score	The PROMIS Depression short-form is an 8 item questionnaire that assesses perceived depression related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of depression.	Baseline, 8 weeks
Change in PROMIS Anxiety short-form score	The PROMIS Anxiety short-form is an 8 item questionnaire that assesses perceived anxiety related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of anxiety.	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chrisandra L. Shufelt, MD, MS, Mayo Clinic; Principal Investigator: Stephanie S. Faubion, MD, MBA, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-002719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes