Demographic and baseline characteristics of women who received ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, conventional 28-day or fixed extended regimen (full analysis set)
| Characteristic | FlexibleMIB (n=642) | Conventional 28-day (n=216) | Fixed extended (n=209) |
|---|---|---|---|
| Age (years) | 24.8 (4.4) | 24.3 (4.3) | 24.8 (4.5) |
| Height (cm) | 167.2 (6.3) | 167.8 (5.8) | 168.0 (6.2) |
| BMI (kg/m2) | 22.5 (2.7) | 22.6 (2.8) | 22.5 (2.6) |
| Caucasian ethnicity [n (%)] | 636 (99.1) | 212 (98.1) | 202 (96.7) |
| Current smokers [n (%)] | 205 (31.9) | 67 (31.0) | 67 (32.1) |
| Contraceptive method at screening [n (%)] | |||
| COCs | 538 (83.8) | 158 (73.1) | 148 (70.8) |
| Condoms | 77 (12.0) | 48 (22.2) | 52 (24.9) |
| None | 17 (2.6) | 7 (3.2) | 5 (2.4) |
| Other | 10 (1.6) | 3 (1.4) | 4 (1.9) |
Data are presented as mean (SD) unless otherwise stated.
The full analysis set was defined as all women who received at least one dose of study medication and had at least one clinical observation after administration of study medication.
BMI, body mass index; MIB, management of intracyclic (breakthrough) bleeding; COCs, combined oral contraceptives.