Ethinylestradiol/drospirenone regimens and number of subjects per group
| Regimen | Active treatment interval (days) | Hormone-free interval (days) | Cycles (n) | Population PK analysis | Subjects receiving treatment* (n) | |
|---|---|---|---|---|---|---|
| EE (n) | DRSP (n) | |||||
| FlexibleMIB | 24–120† | 4 | 3–13 | 671 | 667 | 684 |
| Conventional | 24 | 4 | 13 | 224 | 223 | 229 |
| Fixed extended | 120‡ | 4 | 3 | 214 | 206 | 221 |
| Total | – | – | – | 1109 | 1096 | 1134 |
*See Klipping et al.6
†For the flexible extended regimen with management of intracyclic (breakthrough) bleeding (flexibleMIB), subjects were advised to take one tablet per day for 120 days or until they experienced breakthrough bleeding and/or spotting for three consecutive days. After 120 days of continuous tablet intake or in the event of three consecutive days of bleeding and/or spotting, women were to observe a 4-day tablet-free interval before starting a new cycle; the minimum duration of active treatment in any cycle was 24 days (‘mandatory phase’).
‡For the fixed extended regimen women were to take tablets continuously for 120 days before observing a 4-day tablet-free interval.
DRSP, drospirenone; EE, ethinylestradiol; PK, pharmacokinetic.