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. 2020 Nov 17;38(1):137–148. doi: 10.1007/s12325-020-01555-z

Table 1.

Summary of the PEARL trials with UPA

Study Duration Efficacy Safety profile (adverse effects)
PEARL I 13 Weeks

Bleeding was controlled in 91% of women taking 5 mg and 92% of women taking 10 mg and 19% in placebo

Reduction in fibroid volume was 21%, 12% and 3% for women taking 5 mg, 10 mg and placebo respectively

Amenorrhea rate: 73%, 82% and 6% in women taking 5 mg, 10 mg and placebo respectively

Benign changes on the endometrium were noted on histology but 6 months these were no longer present

Uterine haemorrhage

Myoma projecting through the cervix

Others: headaches and breast tenderness

PEARL II 13 Weeks

Control of bleeding occurred in 90% of women taking 5 mg and 98% of women taking 10 mg and 89% in leuprolide arm

Amenorrhea rate: 5 days, 7 days and 21 days in women taking 5 mg, 10 mg and leuprolide arm respectively

Hypoestrogenic symptoms: 11%, 10% and 40% in women taking 5 mg, 10 mg and leuprolide arm respectively
PEARL III 13 Weeks (repeated courses)

Amenorrhea: 79%, 89%, 88%, 90% for courses 1, 2, 3 and 4 respectively of 10 mg of UPA

Mean reduction in fibroid volume: 45%, 63%, 67% and 72% for the 4 courses of 10 mg of UPA

All endometrial biopsies

Revealed benign changes with no atypia

PEARL IV 12 Weeks (repeated courses)

Control of bleeding was > 80%

Reduction in fibroid volume: 54% and 58% for women taking 5 mg and 10 mg of UPA respectively

Improved quality of life and pain control

Less than 5% of patients discontinued due to untoward effects