User satisfaction, Psychological General Well-Being Index score and menstruation-related symptoms in women who received ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, conventional 28-day or fixed extended regimen (full analysis set)
| Parameter | FlexibleMIB (n=179) | Conventional 28-day (n=18) | Fixed extended (n=43) | |||
|---|---|---|---|---|---|---|
| Regimen satisfaction* [n (%)] | ||||||
| Very satisfied | 111 (62.0) | – | 25 (58.1) | |||
| Quite satisfied | 60 (33.5) | – | 14 (32.6) | |||
| Improved frequency of painful menstruations* [n (%)] | 138 (77.1) | 14 (77.8) | 35 (81.4) | |||
| Improved intensity of painful menstruations* [n (%)] | 133 (74.3) | 16 (88.9) | 38 (88.4) | |||
| PGWBI (change in total score from baseline to Week 51) | +0.35 | −1.02 | +0.26 | |||
| Menstruation-related symptoms [n (%)] | Baseline (n=642) | Week 51 (n=554) | Baseline (n=216) | Week 51 (n=196) | Baseline (n=209) | Week 51 (n=165) |
| Mild abdominal/pelvic pain | 296 (46.1) | 132 (23.8) | 90 (41.7) | 54 (29.0) | 84 (40.2) | 25 (15.2) |
| Mild backache | 158 (24.6) | 94 (17.0) | 57 (26.4) | 30 (16.1) | 57 (27.3) | 19 (11.5) |
| Daily activities slightly impaired | 38 (5.9) | 12 (2.2) | 8 (3.7) | 11 (5.9) | 7 (3.3) | 0 (0) |
| Confined to bed for part of a single day | 14 (2.2) | 7 (1.3) | 3 (1.4) | 0 (0) | 10 (4.8) | 1 (0.6) |
| Leisure activities slightly affected | 72 (11.2) | 19 (3.5) | 18 (8.3) | 9 (4.8) | 19 (13.9) | 6 (3.7) |
↵* Assessed in women who reported painful menstruation before the start of study medication (32.3% of women who received the flexibleMIB regimen, 14.4% of women who received the conventional regimen and 26.1% of women who received the fixed extended regimen).
MIB, management of intracyclic (breakthrough) bleeding; PGWBI, Psychological General Well-Being Index.