Clinical Trials

Inclusion Criteria:

• Currently be between 45-60 years of age.
• Have bothersome VMS, defined as 28 or more hot flashes per week that were present for more than 30 days, and were of sufficient severity to prompt them to seek therapeutic intervention.  
• Able to participate fully in all aspects of the study; and
• Have understood and signed study informed consent.

Exclusion Criteria:

• Non-English speaking.
• Self-reported history of acute and/or severe motion sickness.
• The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted displace (HMD).
• Legally blind or deaf.
• Having had a seizure in the past year.
• Menopause occurring as a result of surgery (bilateral salpingo-oophorectomy with or without hysterectomy) or resulting from cancer treatments (chemotherapy, radiation).
• Current use of hormone therapy for menopause symptoms.
• Current use of fezolinetant
• Current use of supplements or herbal products with claims to relieve menopausal symptoms.
• Current treatment with hypnosis or CBT.
• Current use of weight loss medications.
• Have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder).
• Have used an investigational drug within 30 days of study enrollment.
• Any current (past 4 weeks) or planned use of:
  • Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets). Low dose vaginal estrogen is acceptable;
  • Antineoplastic chemotherapy (anti-HER2 agents allowed);
  • Androgens;
  • Progestogens;
  • Selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs).
• Have current (in the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or endocrine disorder.
• Current active cancer or currently receiving treatment for cancer (including Tamoxifen, raloxifene and aromatase inhibitors); or are within 1 year of cancer remission.
• Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/16/2024. Questions regarding updates should be directed to the study team contact.