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

Inclusion Criteria:

• Participant is diagnosed with bothersome VMS due to/associated with menopause for atleast 3 months based on a standard of care assessment captured in consultation withan HCP including the participant's history, routine physical examination, androutine laboratory assessments.

• HCP has made the clinical decision to begin pharmacologic treatment with a non-HTincluding, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI,gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of thestandard treatment for VMS. This may be the first course of treatment, a restart ora switch from one drug (HT/non- HT) to another non-HT. A restart or switch of aprevious therapy requires a minimum of a 10-day period not on therapy/washout periodprior to pre-baseline.

• Participant's health status is stable based on their medical history and generalphysical exam and determined to be a candidate for treatment with non-HTs.

• If participant has been prescribed an SSRI or SNRI for the treatment of depressionor anxiety, they must be on a stable or consistent dose for a minimum of 3 monthsprior to screening.

• Participant has a negative urine pregnancy test at screening if not post-menopausal.

• Only for participants utilizing complementary and alternative therapies, mind-bodytechniques, or supplements for the treatment of VMS: participant has been on suchtherapies for ≥ 3 months prior to screening and intends to continue through durationof study.

• Confirmation has been made that the participant is able to obtain the prescribed nonhormonal therapy (e.g., insurance coverage verified, participant has ability to selfpay, or patient support program activated for at least 12 months for the uninsuredparticipants, if applicable).

Exclusion Criteria:

• Participant is currently enrolled in any interventional or non-interventionalwearable 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 thetreatment of VMS.

• Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and hasnot had a 10-day washout period prior to pre-baseline (vaginal/local estrogenpreparations and levonorgestrel-releasing intrauterine system are not prohibited).

• Participant has presence of moderately severe or severe depression per standard ofcare 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 bleedingwithin the last 6 months.

• Participant has pre-existing uncontrolled thyroid disease.

• Participant has unstable angina or participant has uncontrolled hypertension basedon a standard of care assessment.

• Participants who do not meet these criteria may be re-assessed after initiationor review of antihypertensive measures.

• Participants with a medical history of hypertension can be enrolled once theyare medically clear (stable and compliant).

• Participant has had insomnia unrelated to either menopause or bothersome VMS dueto/associated with menopause.

• Participant has known substance abuse or alcohol addiction within 6 months ofscreening.

• Participant has been on intramuscular estradiol within 8 weeks of screening.

• Participant has a current diagnosis of a malignancy or history of a malignancywithin the past 2 years (This does not include basal cell carcinoma or breastcancer.)

• Participants with metastatic (Stage 4) breast cancer.

• Participants who have been prescribed adjuvant endocrine therapy (tamoxifen oraromatase inhibitors with or without gonadotropin-releasing hormone analogues) fortheir non-metastatic (stage 0 to 3) breast cancer but have not maintained a stabletreatment regimen for at least 3 months prior to screening.

• Participant has initiated hormone pellet therapy within 6 months of screening.