Abstract
In the pivotal LIBERTY 1 and 2 trials and Long-Term Extension (LTE) study, once-daily relugolix combination therapy (Rel-CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) reduced menstrual blood loss (MBL) volume and pain in women with uterine fibroids (UF). Rel-CT was well tolerated, with preservation of bone mineral density (BMD) through 52 weeks. Here we report results of the Phase 3 LIBERTY randomized withdrawal study (RWS), designed to evaluate the efficacy and safety of Rel-CT for up to 2 years.
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