Table 2 –
Scheduled and unscheduled bleeding and/or spotting during 13 cycles of segesterone acetate/ethinyl estradiol contraceptive vaginal system use
| Scheduled bleeding1 |
Unscheduled bleeding2 |
|||||
|---|---|---|---|---|---|---|
| Cycle | N3 | Bleeding-only Any - n (%) |
Bleeding/Spotting Any - n (%) |
N3 | Bleeding-only Any - n (%) |
Bleeding/Spotting Any - n (%) |
| 1 | 2020 | 1840 (91.1) | 1908 (94.5) | 2029 | 176 (8.7) | 438 (21.6) |
| 2 | 1744 | 1558 (89.3) | 1625 (93.2) | 1754 | 104 (5.9) | 276 (15.7) |
| 3 | 1509 | 1355 (89.8) | 1423 (94.3) | 1520 | 82 (5.4) | 248 (16.3) |
| 4 | 1456 | 1313 (90.2) | 1372 (94.2) | 1460 | 81 (5.5) | 192 (13.2) |
| 5 | 1406 | 1248 (88.8) | 1312 (93.3) | 1417 | 95 (6.7) | 217 (15.3) |
| 6 | 1259 | 1104 (87.7) | 1177 (93.5) | 1267 | 106 (8.4) | 230 (18.2) |
| 7 | 1214 | 1064 (87.6) | 1138 (93.7) | 1214 | 91 (7.5) | 206 (17.0) |
| 8 | 1174 | 1013 (86.3) | 1085 (92.4) | 1178 | 97 (8.2) | 216 (18.3) |
| 9 | 1022 | 873 (85.4) | 947 (92.7) | 1027 | 83 (8.1) | 193 (18.8) |
| 10 | 932 | 805 (86.4) | 872 (93.6) | 939 | 87 (9.3) | 183 (19.5) |
| 11 | 850 | 737 (86.7) | 798 (93.9) | 856 | 74 (8.6) | 172 (20.1) |
| 12 | 780 | 673 (86.3) | 736 (94.4) | 783 | 69 (8.8) | 161 (20.6) |
| 13 | 649 | 537 (82.7) | 597 (92.0) | 713 | 71 (10) | 155 (21.7) |
| Overall | 2055 | 1991 (96.9) | 2011 (97.9) | 2068 | 606 (29.3) | 1165 (56.3) |
Scheduled bleeding and/or spotting (i.e., withdrawal bleeding) was defined as any bleeding and/or spotting (B/S) that occurred during the CVS-out period (Days 22 to 28 of each cycle). Scheduled B/S may have continued uninterrupted into Days 1 to 4 of the subsequent cycle.
For any cycle, days 22-28 must have at least 3 non-missing B/S responses for it to be included in this analysis. Thus, each N may differ from the unscheduled bleeding analyses.
Unscheduled bleeding and/or spotting was defined as any bleeding and/or spotting (B/S) that occurred while using the CVS (i.e., Days 1 to 21 of the cycle), except B/S reported during Days 1 to 7 of the first cycle of CVS insertion or withdrawal bleeding that continued into Days 1 to 4 in subsequent cycles.
For any cycle to be included in this analysis, days 1-21 must have at least 15 non-missing B/S responses. Thus, each N may differ from the scheduled bleeding analyses.
N: total number of participants from pivotal cycle control set analyzed in each cycle. N overall is larger than cycle 1, because some subjects evaluable for later cycles were not evaluable in cycle 1.