A new combo pill can substantially reduce bleeding caused by uterine fibroids -- possibly offering some women yet another alternative to surgery, a new trial finds.
The once-daily medication, which combines a drug called relugolix with estrogen and progestin, is not yet approved in the United States. But it is under review by the U.S. Food and Drug Administration, according to drugmaker Myovant Sciences, which funded the study.
If approved, the drug would join a similar medication -- called Oriahnn -- that got the green light from the FDA last year for reducing heavy bleeding from fibroids.
Fibroids are non-cancerous growths in the wall of the uterus that are usually harmless. But when they cause significant problems -- such as heavy monthly bleeding and persistent pain -- treatment may be necessary.
Traditionally, the go-to has been a hysterectomy, or surgical removal of the uterus. But women who plan to become pregnant or simply don't want a hysterectomy need other options.
One is to have less extensive surgery to remove the fibroids only.
The trouble is that the fibroids often return -- especially when there are multiple growths, said Dr. Taraneh Shirazian, a gynecologist who specializes in minimally invasive surgery at NYU Langone Health in New York City.
Shirazian, who was not involved in the new trial, said she is always interested in alternatives for women who do not want surgery or are not good candidates for it.
Fibroids are exceedingly common, Shirazian pointed out, particularly among women of color: Around 70% of white women and 80% of Black women develop them by age 50.
Often, fibroids do not cause symptoms, and generally wane after menopause, since estrogen helps fuel their growth.
But for women who do have symptoms, hysterectomy has all too often been the solution, said Dr. Ayman Al-Hendy, lead researcher on the trial.
"We do a lot of hysterectomies in the U.S. every year -- around 600,000," said Al-Hendy, a professor of obstetrics and gynecology at the University of Chicago. "Most of them are done to treat fibroids."
For their trial, Al-Hendy and his colleagues recruited 770 women from several countries, including the United States. All had heavy menstrual bleeding from fibroids and were randomly assigned to take either the drug combination or a placebo for six months.
The treatment involves a tablet of relugolix, which blocks the activity of a natural hormone known as GnRH. That, in turn, suppresses the ovaries from churning out estrogen and progesterone.
To help counter the negative effects of suppressing those hormones -- like decreasing bone density -- the trial patients also took a capsule of synthetic estrogen and progesterone as an "add-back."
Over six months, the trial found, more than 70% of the study patients saw a substantial reduction in their menstrual bleeding, according to findings published Feb. 17 in the New England Journal of Medicine.
A big advantage of oral medication over hysterectomy is that younger women can preserve their fertility, Al-Hendy said.
A downside is that despite the hormonal add-back, some bone loss can occur. Because of that, the FDA approved Oriahnn to be used for only up to two years.
In this trial, though, there was a positive signal: Bone density was no lower in women who took the relugolix combination therapy, than in those on the placebo.
That raises the possibility, Al-Hendy said, that the relugolix combination might be a bit easier on bone density and could be used for a longer stretch.
Shirazian agreed, but also said longer-term data are needed to answer that question.
For now, both doctors said the oral medications could be seen as "a bridge to something else" for certain patients.
Shirazian pointed to one scenario: women who are close to menopause and need symptom relief just until the fibroids naturally recede.
Al-Hendy said medication could also be a shorter-term option for women who plan to become pregnant in the near future.
There is, however, an issue of cost. GnRH blockers are expensive, and the average retail price for Oriahnn is reportedly around $1,000 for a month supply. Depending on a woman's insurance coverage, Al-Hendy said, the price tag could be an obstacle.
The American College of Obstetricians and Gynecologists has more on uterine fibroids.
SOURCES: Ayman Al-Hendy, MD, PhD, professor, obstetrics and gynecology, University of Chicago Medicine; Taraneh Shirazian, MD, associate professor, obstetrics and gynecology, NYU Grossman School of Medicine, and director, Global Women's Health, NYU Global Institute of Public Health, New York City; New England Journal of Medicine, Feb. 18, 2021