Schlaff WD, et al. - Researchers performed two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials to investigate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal “add-back” therapy (to replace decreased levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. They enrolled in an elagolix-alone group to evaluate the effect of add-back therapy on the hypoestrogenic effects of elagolix. They randomized a sum of 412 women in UF-1 and 378 women in UF-2 to receive elagolix or placebo. In women with uterine fibroids, elagolix with add-back therapy was found to be effective in reducing heavy menstrual bleeding.