Once-daily elagolix significantly reduces heavy menstrual bleeding for premenopausal women

Key takeaways:

• Nearly half of the elagolix group had reduced menstrual blood volume and at least a 50% reduction from baseline.
• More participants in the elagolix group had bleeding suppression vs. the placebo group.

Elagolix 150 mg once daily significantly reduced heavy menstrual bleeding from uterine leiomyomas among premenopausal women, according to trial results published in Obstetrics & Gynecology.

“Hormonal add-back therapy has been shown to mitigate the hypoestrogenic side effects of gonadotropin-releasing hormone antagonism, especially reduction in bone mineral density,” Eric L. Brown, MD, FACOG, board-certified obstetrician and gynecologist at Gyn-Care in Atlantic Station, Atlanta, and colleagues wrote. “However, the combination of elagolix with hormonal add-back therapy can be contraindicated in certain situation, such as in some patients who have a history of thromboembolic disease, who have risk factors for thromboembolic disorders, who have a history of breast cancer or who prefer not to use hormonal add-back therapy.”

Brown and colleagues conducted a phase 4, randomized, double-blind, placebo-controlled, multicenter 6-month treatment study of 82 premenopausal women aged 18 to 51 years from 23 U.S. sites. All participants had heavy menstrual bleeding associated with uterine leiomyomas. Heavy menstrual bleeding was defined as blood loss greater than 80 mL during one menses. Participants were randomly assigned to elagolix 150 mg once daily (AbbVie; n = 54;) or placebo (n = 28).

The primary outcome was a reduced menstrual blood loss volume of less than 80 mL during the final study month and at least a 50% reduction in menstrual blood loss volume from baseline to the end of the study.

Nearly half of participants who received elagolix had reduced menstrual blood volume of less than 80 mL and at least a 50% reduction in menstrual blood loss volume from baseline compared with less than one-quarter of participants who received placebo (49.4% vs. 23.3%; P = .035). Researchers observed statistically significant differences in mean menstrual blood loss reduction from baseline between the elagolix and placebo groups as early as the first month.

Compared with the placebo group, more participants in the elagolix group experienced bleeding suppression (37.8% vs. 13%; P = .036). In addition, researchers noted greater improvements in the proportion of participants with amenorrhea, in hemoglobin concentrations and in health-related quality of life among participants in the elagolix group compared with the placebo group.

Overall, 51.9% of participants who received elagolix and 39.3% of participants who received placebo reported adverse events. The most common adverse events were headache (13% vs. 3.6%) and hot flash (11.1% vs. 3.6%) in the elagolix and placebo groups, respectively. In total, three participants discontinued elagolix treatment due to adverse events. In the placebo group, 7.1% of participants reported serious adverse events compared with no serious or severe adverse events reported by the elagolix group.

“This regimen may be considered in patients with contraindications to hormonal add-back therapy or who prefer a nonhormonal therapy with once-daily dosing,” the researchers wrote.