Myovant Sciences…and Pfizer…today announced positive data from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.
…The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001).
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