A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Exclusion Criteria

• •Participant is currently enrolled in any interventional or non-interventional wearable device study.
• •Participant has any condition which makes the participant unsuitable for the study.
• •Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
• •Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
• •Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
• •Participant is currently pregnant or planning to become pregnant.
• •Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
• •Participant has pre-existing uncontrolled thyroid disease.
• •Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.
• •* Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
• •* Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
• •Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
• •Participant has known substance abuse or alcohol addiction within 6 months of screening.
• •Participant has been on intramuscular estradiol within 8 weeks of screening.
• •Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
• •Participants with metastatic (Stage 4) breast cancer.
• •Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
• •Participant has initiated hormone pellet therapy within 6 months of screening.