Characteristics of intracyclic bleeding in women who received ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, conventional 28-day or fixed extended regimen (full analysis set)
| Characteristic | FlexibleMIB (n=622) | Conventional 28-day (n=213) | Fixed extended (n=190) |
|---|---|---|---|
| Number of intracyclic bleeding days | |||
| Bleeding/spotting | 6.6 (8.7) | 6.7 (13.5) | 29.7 (32.9) |
| Bleeding only | 2.2 (4.5) | 3.7 (8.5) | 18.9 (29.2) |
| Number of intracyclic bleeding/spotting episodes | 2.8 (3.4) | 1.7 (2.8) | 4.2 (3.8) |
| Maximum length of intracyclic bleeding/spotting episodes | 4.1 (4.0) | 5.8 (4.9) | 16.5 (14.8) |
| Maximum intensity* of intracyclic bleeding | 2.7 (0.9) | 3.0 (0.9) | 3.2 (1.0) |
Data are presented as mean (SD).
↵* Intensity scores: 1, none; 2, spotting; 3, light; 4, normal; 5, heavy.
The full analysis set was defined as all subjects who received at least one dose of study medication and had at least one clinical observation after administration of study medication.
MIB, management of intracyclic (breakthrough) bleeding.