Ulipristal acetate: Phase III data
Top-line data from the double-blind Phase III Venus I trial in 157 premenopausal women ages 18-50 with uterine fibroids showed that 5 and 10 mg ulipristal acetate for 12 weeks each met the co-primary endpoints of a greater proportion of patients with absence of uterine bleeding (47.2% and 58.3%, respectively, vs. 1.8%, p<0.0001 for both) and of improving time to absence of uterine bleeding (p<0.0001 for both) vs. placebo. Low- and high-dose ulipristal acetate also met the secondary endpoints of a greater proportion of patients with absence of uterine bleeding from day 11 to end of treatment (43.4% and 58.3%, respectively, vs. 0%, p<0.0001 for both) and change from baseline in the UFS-QOL revised Activities subscale score at the end of treatment (52.1 and 59 points, respectively, vs. 21.2 points, p<0.0001 for both) vs. placebo. ...