Loading...
Uterine fibroids often cause heavy menstrual bleeding. Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist approved by the FDA for management of pelvic pain caused by endometriosis. To study the efficacy of elagolix (alone or with estrogen-progestin add-back therapy) in the setting of uterine fibroids, two identical industry-supported trials were performed. A total of 790 women in both trials (mean age, 42) with heavy menstrual bleeding (>80 mL blood loss per cycle), and ultrasound-diagnosed uterine fibroids were randomized to elagolix (300 mg twice daily) plus add-back (1 mg estradiol and 0.5 mg norethindrone acetate once daily), elagolix alone, or placebo for 6 months. Menstrual blood loss was quantified on collected sani…