Cooling hot flashes: UVA professor tests new treatment

JoAnn Pinkerton (Col class of ’76, Res class of ’85) knew the women she was treating.

They were busy taking care of their small children and teenagers; they were looking after aging parents; they were trying to balance their home life and their work life. And in the midst of that, “they weren’t paying attention to themselves,” she said. 

Pinkerton, a professor of obstetrics and gynecology and director of UVA’s Midlife Center, has long viewed menopause as a key area for research into treatments that could help her patients sleep better, feel better, function better, work better, eat healthier, exercise more, and improve their relationships professionally and at home.

Now she is hopeful that help is on the way, in the form of a pill taken once a day.

For the past several years, Pinkerton has been working with the drug company Bayer on studies involving a medicine known as elinzanetant. In a pair of studies that began in August 2021 and ran through October 2023, researchers recruited women ages 40 to 65 who had completed menopause and were seeking treatment for hot flashes. 

The studies took place at 155 sites across the United States and Europe. Pinkerton was the principal investigator at UVA, which was the lead site for the United States. Women enrolled in the study had upward of 50 hot flashes a week.

“Hot flashes themselves are not just a nuisance, but they’ve got health risks,” Pinkerton said, citing that they’ve been independently correlated to bone loss and cardiovascular, metabolic and cognitive issues. “It’s really a major, major issue.” Hot flashes also contribute to sleep, mood and quality-of-life disturbances, all of which were evaluated in the studies.

In blind trials that lasted 26 weeks, more than 80 percent of women saw at least a 50 percent reduction in their hot flashes, Pinkerton said.

The treatment works by treating two receptors in the brain known as neurokinen 1 and neurokinen 3. The therapy helps modulate estrogen-sensitive neurons in the hypothalamus region of the brain. With the decrease of estrogen, those neurons can create a hyperactivation of the thermoregulatory pathway, which disrupts control of body heat. 

Elinzanetant is awaiting Food and Drug Administration approval, which could come as soon as this spring, Pinkerton said. The medicine, whose side effects can include headaches and fatigue, will also need to be approved and made available by insurance companies, she said.

In another study that’s expected to last a year, researchers are looking to see if elinzanetant reduces sleep disturbances. That means women would fall asleep faster, with fewer disruptions and higher-quality sleep overall.

Elinzanetant is a nonhormonal treatment. Many women, including those who have had breast cancer, uterine cancer, strokes, blood clots or migraine headaches, can’t receive hormone treatments as a way to manage symptoms.

And while there are nonhormonal treatments available, none are FDA-approved.

“This is really a new era in menopause management,” said Chrisandra Shufelt, a women’s health internist at the Mayo Clinic in Jacksonville, Florida. “What’s more exciting about this one specifically is that while it is important for hot flashes and night sweats, it could also cover some other symptoms that we see at menopause that really do affect quality of life in these women—things like sleep and weight.”