Many people are familiar with the short-term symptoms of menopause, such as hot flashes, which are caused by changes in reproductive hormones. Yet what they may not realize is that menopause can compromise heart and brain health in the long term.
Atherosclerosis, or the buildup of plaque in the arteries, is the primary cause of death in the United States and almost always affects postmenopausal women. Memory loss, dementia, and Alzheimer’s disease are much more common in postmenopausal women than in premenopausal women.
Now USC’s Keck Medicine has launched a clinical trial to study the effect of a new hormone replacement therapy on postmenopausal cardiovascular disease and cognitive decline.
“The data support the concept that estrogen, a hormone that the ovaries stop producing after menopause, protects both the heart and the brain from damage,” said Howard N Hodis, MD, director of the USC Atherosclerosis Research Unit, an internal medicine specialist at Keck Medicine and lead investigator of the study. “Our study seeks to determine whether hormone therapy containing estrogen can prevent or slow the progression of atherosclerosis and cognitive impairment in postmenopausal women.”
A key aspect of the study is that it is designed for women who are six years or less post-menopausal.
“We’ve looked at previous data and done clinical trials that show that the timing of when a woman starts hormone therapy is critical,” said Hodis, who is also a professor of medicine and population and public health sciences at USC’s Keck School of Medicine. “There appears to be a limited window of time when women benefit from hormone replacement therapy. After six years of menopause, prevention seems too late.’
Improving standard hormone replacement therapy
The hormone therapy being studied has been approved by the Food and Drug Administration since 2013 and consists of estrogen paired with a non-hormonal drug known as bazedoxifene.
Traditional hormone replacement therapy combines estrogen with progesterone, or more commonly with progestin, synthetic progesterone. Estrogen alone can cause the lining of the uterus to thicken, causing bleeding and other health problems that progesterone or progestin prevents.
However, progestin/progesterone in combination with estrogen is associated with cancer risks. Bazedoxifene prevents thickening of the uterine lining, while it doesn’t appear to pose the same risks, Hodis said.
Eligibility and protocols
The clinical trial, called Advancing Postmenopausal Preventive Therapy, is open to healthy women six years or less after menopause who have a uterus, are aged 45-59 and do not have cardiovascular disease.
After registration, trial participants:
Get an ultrasound of their carotid artery, which is used as a non-invasive baseline measure of atherosclerosis.
Take several tests to measure their basic cognitive function and memory
Every six months, participants have a carotid ultrasound to monitor for any progression of atherosclerosis. They also have electrocardiograms to check for various heart conditions that are done annually.
At the end of the study, which lasts about three years, the women will take cognitive and memory tests again so the researchers can determine if there has been any change since being enrolled in the study.
The clinical trial is a double-blind, placebo-controlled trial, meaning that neither the participants nor the researchers know who is receiving hormone replacement or a placebo. After the clinical trial is complete, the researchers will compare the results between those receiving the therapy and the placebo, and the participants will be told which option they received.
So far, about 260 women are participating in the trial; researchers are looking for an additional 100 women to enroll. Those interested in participating should contact the USC Atherosclerosis Research Unit at (323) 442-2257. “Our ultimate goal is to help women and their doctors make informed decisions to promote good health after menopause,” said Hodis.
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