NCT07633743

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Menopause

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score

    Baseline, 8 weeks

  • Change in Menopause Rating Scale (MRS) score

    Baseline, 8 weeks

  • System Usability Scale (SUS) score

    8 weeks

  • Change in Simulator Sickness Questionnaire (SSQ) score

    Baseline, 8 weeks

  • Change in PROMIS Sleep Disturbance short-form score

    Baseline, 8 weeks

  • +2 more secondary outcomes

Study Arms (1)

MenoZen

EXPERIMENTAL

Menopausal women will participate in weekly virtual reality sessions using the MenoZen VR program.

Device: MenoZen

Interventions

MenoZenDEVICE

Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.

MenoZen

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Chrisandra L. Shufelt, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Stephanie S. Faubion, MD, MBA

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Uy

CONTACT

904-953-5337Uy.Lauren@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)