Table 1.
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 |