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

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined.

Inclusion Criteria:

• Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
• HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
• Participant's health status is stable based on their medical history and general physical 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 depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
• Participant has a negative urine pregnancy test at screening if not post-menopausal.
• Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months prior to screening and intends to continue through duration of study.
• Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).

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.