Recruiting

MenoZen VR

Sponsor:

Mayo Clinic

Code:

NCT07633743

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Interventions

MenoZen

Study Details

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.

Conditions

Menopause

Study ID

NCT07633743

Start date

Sep 28, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MenoZen

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

Interventions

MenoZen

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

Primary outcome measure

  • Change in frequency of hot flashes [ Time Frame: Baseline, 8 weeks ]
  • Change in severity of hot flashes [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.