Skip to main content
. 2018 Jun 24;2018:1374821. doi: 10.1155/2018/1374821

Table 1.

Most important results from studies PEARL I–III [11, 23, 24].

  Study design Study drug/- duration Inclusion criteria Study population Primary endpoints and results Secondary endpoints and results
PEARL I [23] 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
PEARL II [11] double-blind, randomized 
parallel group, 
double-dummy, noninferiority trial 		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 %
PEARL III [24] 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

PBAC: pictorial blood-loss assessment chart; UPA: ulipristal acetate; LA: leuprorelin acetate; NETA: norethisterone acetate.