A Win for Women With Symptomatic Uterine Fibroids

Andrew M. Kaunitz, MD


December 14, 2022

This transcript has been edited for clarity.

Uterine leiomyomas or fibroids represent the most common indication for hysterectomy in US women, with the burden of this disease disproportionately born by Black women.

Gonadotropin-releasing hormone (GnRH) antagonists comprise a new class of orally active medications which bind to GnRH receptors, thereby rapidly and reversibly suppressing ovarian steroid production.

Combined with estradiol-norethindrone add-back therapy, two GnRH antagonists — elagolix and relugolix — are currently US Food and Drug Administration (FDA)–approved for the treatment of heavy menstrual bleeding associated with uterine fibroids for up to 6 months. Full disclosure: I participate on an advisory board for Myovant, manufacturer of relugolix.

Used alone, the profound hypoestrogenism caused by GnRH antagonists results in loss of bone mineral density (BMD). This decline in BMD is attenuated by hormone add-back therapy.

In the December issue of ACOG's Green Journal [Obstetrics & Gynecology], investigators present results of a 52 week trial of relugolix combined with add-back therapy in women with fibroids and heavy menstrual bleeding.

This study found that the profound suppression of heavy bleeding noted in earlier 6-month trials was sustained over 1 year of use, with a mean reduction in menstrual blood loss of 89.9%, with 70% of participants achieving amenorrhea.

With respect to BMD, loss at the spine at 52 weeks was less than 1%. To put that minimal loss of BMD in perspective, lactation, a hypoestrogenic condition, is associated with a 3%-5% loss of BMD, and this loss reverses rapidly after the baby is weaned.

GnRH antagonists, already approved as combination agents for the treatment of heavy menstrual bleeding associated with fibroids and for pain associated with endometriosis, have great potential to treat other common gynecologic conditions that are dependent on ovarian steroid production, including uterine adenomyosis and polycystic ovarian syndrome.

It is my hope that these reassuring 52-week data will lead to eventual approval of combined GnRH antagonist therapy for longer periods of time, thereby increasing the clinical utility of these novel and important agents.

I am Andrew Kaunitz. Please take care of yourself and each other.

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