The most common side effects in both groups were hot flashes and headaches. Severe side effects were rare. However, compared with women taking only elagolix, women on elagolix with add-back therapy had fewer and less severe hot flashes and night sweats, and experienced much less loss of bone mineral density (although both groups demonstrated bone loss).

Based on a questionnaire given to both groups, women taking elagolix with add-back therapy reported a better quality of life.

Who might find this new option helpful?

This new FDA-approved medication could potentially be an excellent option for women who would like to avoid surgery and try medical management of their fibroids instead. The caveat is that the trial studied this drug for 12 months. The FDA has not approved its use for more than 24 months, so this may not be a lifelong solution for patients.

However, elagolix with add-back therapy could be an excellent option for women who are perimenopausal, will likely go through menopause in one to two years, and want to avoid a hysterectomy. It would also be an excellent option for women who are interested in conceiving in one to two years and would like to decrease menstrual bleeding without resorting to surgery.

Women seeking long-lasting relief from heavy menstrual bleeding due to fibroids have long been told that their best option is a hysterectomy. This new data may have the potential to change that advice.

(Huma Farid, M.D., is a contributor to Harvard Health Publications.)

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