double-blind, randomized, placebo controlled, multicenter, parallel group
UPA 5 mg/d vs. UPA 10 mg/d vs. placebo Duration: 12 Weeks All patients received iron supplementation
women with uterine fibroids,hypermenorrhea (PBAC> 100), anemia (Hb < 10,2 g/dl), eligible to undergo fibroid surgery after the end of the treatment period
UPA 5 mg: N = 96 UPA 10 mg: N = 98 Placebo: N = 48
Percendays of patients with control of uterine bleeding (PBAC < 75) at week 13: UPA 5 mg: 91 UPA 10 mg: 92 Placebo: 19 P < 0,001 Reduction of fibroid volume compared to baseline (median) at week 13: UPA 5 mg: -21,2 UPA 10 mg: -12,3 ∗∗ Placebo: +3 P = 0,002 P = 0,006
Percendays of patients in amenorrhea at week 13: UPA 5 mg: 73 % UPA 10 mg: 82 % Placebo: 6 % P < 0,001 Menstrual bleeding: PBAC at baseline (median) UPA 5 mg: 386 UPA 10 mg: 330 Placebo: 376 vs. at week 13: UPA 5 mg: -329 UPA 10 mg: -326 Placebo: -59 P < 0,001
UPA 5 mg/d vs. UPA 10 mg/d vs. Leuprorelin Acetate (LA) 3,75 mg i.m. /1x Month Duration: 12 weeks
Women with uterine fibroids, Hypermenorrhea, all patients eligible for uterine fibroid surgery
UPA 5 mg: N = 93 UPA 10 mg: N = 95 LA: N = 93
Percendays of patients with controlled bleeding (PBAC < 75) at week 13: UPA 5 mg: 90 UPA 10 mg: 98 ∗∗ LA: 89 1,2 (95 CI: -9,3 to 11,8) 8,8 (95 CI: 0,4 to 18,3)
Percendays of patients with amenorrhea at week 13: UPA 5 mg: 75 % UPA 10 mg: 89 % LA: 80 % Median change in fibroid volume of the 3 largest fibroids at baseline and at week 13: UPA 5 mg: -36 % UPA 10 mg: -42 % LA: -53 %
Long-term phase III UPA treatment Courses Open NETA treatment corses: double-blind, placebo controlled, randomized
Per treatment course: UPA 10 mg/d for 12 weeks followed by NETA 10 mg/d for 10 days or placebo for a total of 4 treatment courses
Women with symptomatic uterine fibroids, eligible for uterine fibroid surgery
UPA treatment Treatment course 1 N = 132 Treatment course 2 N = 131 Treatment course 3 N = 119 Treatment course 4 N = 107
Patients in amenorrhea after each treatment course Treatment course 1: 79,5 % Treatment course 2: 88,5 % Treatment course 3: 88,2 % Treatment course 4: 89,7 %
Median change in fibroid volume of the 3 largest fibroids at baseline Treatment course 1: -45 % Treatment course 2: -63 Treatment course 3: -67 % Treatment course 4: -72 time to amenorrhea Treatment course 1: 4 Days Treatment course 2: 2 Days Treatment course 3: 3 Days Treatment course 4: 3 Days