Table II –
Number of bleeding and/or spotting days according to the ulipristal acetate dose released by a copper intrauterine system during a 12-week treatment period
| UPA dose | Baseline | Treatment cycle 1 | Treatment cycle 2 | Treatment cycle 3 |
|---|---|---|---|---|
|
| ||||
| Bleeding and Spotting days - mean (SD) | ||||
|
| ||||
| 5 μg/d (n= 8) | 6.1 (2.3) | 8.0 (3.9) | 6.4 (3.9) | 6.0 (2.3) |
| 20 μg/d (n=10) | 7.0 (2.4) | 8.3 (4.6) | 6.7 (2.9) | 5.8 (2.7) |
| 40 μg/d (n=9) | 5.9 (1.8)a | 7.0 (2.4) | 4.6 (2.9) | 3.7 (1.7)a |
|
| ||||
| Bleeding-only days - mean (SD) | ||||
|
| ||||
| 5 μg/d (n= 8) | 3.6 (2.7) | 5.1 (5.1) | 3.2 (3.2) | 3.0 (2.7) |
| 20 μg/d (n=10) | 4.2 (1.0) | 4.4 (2.5) | 3.1 (3.5) | 2.5 (3.1) |
| 40 μg/d (n=9) | 3.9 (2.3)b,c | 3.7 (1.4) | 1.4 (1.5)b | 0.9 (1.4)c |
|
| ||||
| Spotting-only days - mean (SD) | ||||
|
| ||||
| 5 μg/d (n= 8) | 3.2 (0.7) | 3.7 (2.1) | 3.6 (2.8) | 3.4 (1.1) |
| 20 μg/d (n=10) | 3.4 (2.2) | 4.9 (3.7) | 4.0 (1.1) | 3.8 (2.1) |
| 40 μg/d (n=9) | 2.6 (2.0) | 3.8 (2.3) | 3.3 (2.4) | 2.8 (1.9) |
UPA: Ulipristal acetate; SD: Standard deviation
Same letters (a, b, c) indicate a comparison with p < 0.05.
Bleeding and spotting, bleeding-only, and spotting-only days analyzed by a generalized linear mixed model with orthogonal contrasts
Per protocol population includes all participants who completed 12 weeks of intrauterine system use (n=27)