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.
