Definitions of withdrawal bleeding, intracyclic bleeding and scheduled and unscheduled bleeding in women who received ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, fixed extended or conventional 28-day regimen
| Term | FlexibleMIB | Fixed extended | Conventional 28-day |
|---|---|---|---|
| Withdrawal bleeding | Started before or at the latest on the fourth day of the subsequent cycle AND ended at the earliest 4 days before the first day of the tablet-free interval of the current cycle or later | Started on or after Day 21 of the cycle and lasted until at least Day 25 of the same cycle OR started on or after Day 25 of the cycle, but before Day 25 of the next cycle | |
| If more than one episode satisfied both of the above criteria, the first episode to occur was considered to be the withdrawal bleeding episode of that cycle | If more than one episode satisfied either of the above criteria, the first episode to occur was considered to be the withdrawal bleeding episode of that cycle | ||
| Intracyclic bleeding | Bleeding episodes (either spotting or bleeding) shorter than 3 days | ||
| All other (unexpected) bleeding episodes | All other (unexpected) bleeding episodes | ||
| Scheduled bleeding | Any bleeding days that occurred during the tablet-free interval or up to 4 days after the tablet-free interval | Not evaluated* | |
| Unscheduled bleeding | Any bleeding days that occurred while taking active treatment, unless they occurred (i) up to 4 days after the tablet-free interval or (ii) during Days 1–7 of the first treatment cycle | Not evaluated* | |
↵* As tablet-free intervals were not documented with the conventional 28-day regimen, an analysis of scheduled and unscheduled bleeding was only conducted for the two extended regimens.
MIB, management of intracyclic (breakthrough) bleeding.