Do you Feel that Recent Studies have Answered all Your Questions about Whether Hormone Therapy is Right for You?
Many women don’t, especially women who have a uterus. That’s why we would like you to know about APPT, a study of a new FDA-approved menopausal hormone therapy for women with a uterus.
Menopause is a difficult time for most women. To make matters worse, studies are confusing as to whether hormone therapy is good or bad.
Estrogen continues to show great promise as women in the Women’s Health Initiative (WHI) who were less than 60 years of age when started on estrogen alone tended to have less heart disease, less breast cancer and less death than women who were not started on estrogen. However, most women have a uterus that requires use of other hormones such as progestin or progesterone, which when combined with estrogen appear to carry the greatest risk for women. The new FDA-approved therapy for women with a uterus, bazedoxifene/estrogen does not contain the hormones progestin or progesterone.
APPT participants undergo health screening at the beginning of the study and followed closely during the study. If you are unsure about the pros and cons of menopausal hormone therapy, APPT is a way to help get answers and to contribute to the advancement of women’s health in a carefully monitored setting.
What is APPT?
APPT is a randomized trial designed to study the effects of bazedoxifene/estrogen on atherosclerosis, cognition (thinking, memory, mental function) and other postmenopausal health issues. Atherosclerosis and cognitive decline are the greatest long-term issues that plague postmenopausal women.
What is Atherosclerosis?
Atherosclerosis (hardening of the arteries) is the accumulation of cholesterol-containing plaques in arteries and is the foremost cause of death in the United States today. It can block circulation of blood to the heart and brain, causing a heart attack, angina (chest pain), and stroke. This condition, known as cardiovascular disease, is responsible for 1 million deaths in the United States each year.
How Are You Affected?
Cardiovascular disease is the leading cause of death killing 1 of every 2-3 women. Atherosclerosis, the cause of cardiovascular disease, accounts for approximately 500,000 deaths each year in American women; more than the next 7 causes of death in women combined, including breast cancer. Before menopause, women have a very low risk of suffering from a cardiovascular event, possibly protected by estrogen. More than 90% of deaths due to atherosclerosis occur after menopause, when a women’s production of estrogen disappears.
What Will We Learn from APPT?
We hope to learn whether the combination bazedoxifene/estrogen therapy has beneficial effects on hardening of the arteries in menopausal women. In addition, hot flashes, moodiness, depression and memory will be followed for bazedoxifene/estrogen effects on quality of life and cognition.
You May Qualify if You:
are 45-59 years of age
are less than 6 years past menopause
have a uterus
do not have heart disease
do not have diabetes
are willing to take study pills daily for 3 years
What is Expected of the Volunteer Participant?
Participation is for 3 years after the screening period. During this time, the participant will come to the Atherosclerosis Research Unit on the USC Health Sciences Campus every 1 to 2 months for clinical evaluation, blood tests and noninvasive imaging of the arteries of the neck for atherosclerosis. Participants will take the study pills daily and avoid using menopausal hormone therapy during the trial. Each participant is also expected to keep daily diaries of hot flashes.
Need help to decide and determine your eligibility?
Call us at (323) 442-2257 between 8:30 AM and 5:00 PM orto determine whether you can join the study.