Table 3.
Median number of bleeding or spotting days and unscheduled bleeding or spotting days by reference period. Study 1 and study 2 and early study withdrawal associated with abnormal uterine bleeding
| Statistics | Study 1 | Study 2 | ||
|---|---|---|---|---|
| DRSP 4 mg (n = 713) | DRSP 4 mg (n = 858) | Desogestrel 0.075 mg (n = 332) | ||
| Cycles 2‐4 | n/N (%) | 11.0 (1.5%) | 10.0 (1.2%)b | 12.0 (3.6%) |
| Cycles 5‐7 | n/N (%) | 8.0 (1.1%) | 6.0 (.7%) | 7.0 (2.1%) |
| Cycles 8‐10/7‐9a | n/N (%) | 6.0 (.8%) | 6.0 (.7%) | 7.0 (2.1%) |
| Cycles 11‐13 | n/N (%) | 5.0 (.7%) | ||
| Unscheduled | ||||
| Cycles 2‐4 | n/N (%) | 6.0 (.8%) | 5.0 (0.6%)c | 12.0 (3.6%) |
| Cycles 5‐7 | n/N (%) | 5.0 (0.7%) | 4.0 (0.5%)b | 7.0 (2.1%) |
| Cycles 8‐10/7‐9a | n/N (%) | 3.0 (0.4%) | 4.0 (0.5%)b | 7.0 (2.1%) |
| Cycles 11‐13 | n/N (%) | 3.0 (0.4%) | ||
| Early study withdrawal associated with abnormal bleeding | n/N (%) | 30 (4.2%) | 28 (3.3%) | 22 (6.6%) |
Abbreviation: DRSP, drospirenone.
a
8‐10 for Study 1, 7‐9 for Study 2.
b
P <0.05 for DRSP 4 mg vs desogestrel.
c
P <0.001 for DRSP 4 mg vs desogestrel.