- The P-III LIBERTY 1 study results involves assessing of relugolix (40mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)/relugolix (40mg) as monothx. + relugolix combination therapy vs PBO in 388 women in ratio (1:1:1) with uterine fibroids and heavy menstrual bleeding for 24wks.
- The P-III LIBERTY 1 study results: response rate (73.4% vs 18.9%); AEs (62% vs. 66%); 84.3% reduction in menstrual blood loss; maintained bone mineral density; reduction in pain; improvement in anemia; Improvement in QoL; well tolerated
- Relugolix is an oral GnRH receptor antagonist, reduces the ovarian estradiol production and is also evaluated in P-III LIBERTY 2 study with its expected results in Q3’19 and NDA submission to the US FDA in Q4’19
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