Table 2.

Adequacy of biopsies, observed lesions, non-physiological tissue, extensive cyst formation, and endometrium thickness >16 mm at screening and after 13 and 38 weeks (data from two Phase III studies, PEARL I and II)22,23,26

	PEARL I			PEARL II
	Placebo (n=48)	UPA 5 mg (n=95)	UPA 10 mg (n=98)	UPA 5 mg (n=97)	UPA 10 mg (n=103)	GnRHa (n=101)
Adequacy of biopsies (%)
Screening	100	92.6	96.9	91.8	97.1	90.1
Week 13 (end of treatment)	95.1	94.0	96.3	91.5	96.9	92.6
Week 38	96.8	95.2	96.8	92.1	92.5	93.7
Observed lesions (n)
Screening	–	1 H	–	1 H, 2 P	–	1 P
Week 13 (end of treatment)	–	1 P	1 P	1 H, 1 P	1 P	1 P
Week 38	1 H	1 P	–	–	–	1 H
Nonphysiological tissue (%)
Screening	8.4	10.0	8.5	6.1	6.4	4.4
Week 13 (end of treatment)	14.4	74.2	70.4	65.1	64.7	17.7
Week 38	7.1	14.2	12.9	17.3	9.9	11.2
Extensive cyst formation (%)
Screening	0	0.4	0	0	0.7	0.7
Week 13 (end of treatment)	0.9	45.1	41.1	37.6	38.2	3.6
Week 38	0	5.1	3.9	4.2	0.5	3.9
Endometrium thickness >16 mm (%)
Screening	0	1.1	2.3	5.2	5.0	4.0
Week 13 (end of treatment)	2.1	11.2	8.0	11.8	15.3	1.1
Week 38	4.2	4.8	2.6	6.0	2.9	4.4

Abbreviations: GnRHa, leuprolide; H, hyperplasia; P, polyp; UPA, ulipristal acetate.