Bleeding pattern outcomes by 90-day reference period in women who received ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, conventional 28-day or fixed extended regimen (full analysis set)
| Reference period | FlexibleMIB | Conventional 28-day | Fixed extended |
|---|---|---|---|
| Bleeding/spotting days | |||
| 1 | 13.7 (n=605) | 22.6 (n =203) | 21.7 (n =182) |
| 2 | 10.7 (n =575) | 15.3 (n =198) | 16.0 (n =174) |
| 3 | 9.4 (n =554) | 14.8 (n =189) | 14.1 (n =161) |
| 4 | 8.2 (n =522) | 14.2 (n =171) | 9.4 (n =146) |
| Spotting-only days | |||
| 1 | 6.5 | 8.0 | 12.7 |
| 2 | 5.4 | 5.0 | 9.8 |
| 3 | 4.7 | 4.9 | 9.0 |
| 4 | 4.3 | 4.7 | 6.8 |
| Bleeding-only days | |||
| 1 | 7.2 | 14.6 | 9.0 |
| 2 | 5.3 | 10.2 | 6.3 |
| 3 | 4.6 | 9.8 | 5.1 |
| 4 | 3.9 | 9.5 | 2.6 |
All data refer to mean values.
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.
Subject numbers shown for bleeding/spotting days apply to the data for spotting-only days and bleeding-only days.
Reference periods 1, 2, 3 and 4 refer to Days 1–90, 91–180, 181–270 and 271–360, respectively.
NB. The greatest number of bleeding/spotting days, spotting-only days and bleeding-only days was reported in the first reference period, which was not unexpected. For all three groups, subjects initiated intake of study medication on the first day of menstrual or withdrawal bleeding after baseline. Therefore, the first reference period contained additional bleeding days (associated with the menstrual cycle prior to the start of study medication) compared with the subsequent reference periods.
MIB, management of intracyclic (breakthrough) bleeding.