Table 1.
Baseline demographic and clinical characteristics (safety set) enrolled in phase 3, multicenter, 13-cycle trial of a drospirenone 4 mg 24/4-day contraceptive regimen
| Non-breastfeeding women |
Breastfeeding women |
Total |
|
|---|---|---|---|
| n = 995 | n = 11 | n = 1006 | |
| Age, years (Mean ± SD) | 27.5 ± 5.95 | 27.0 ± 4.96 | 27.5 ± 5.94 |
| ≤ 35 years, n (%) | 917 (92.2) | 11 (100.0) | 928 (92.2) |
| > 35 years, n (5) | 78 (7.8) | 0 | 78 (7.8) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 226 (22.7) | 3 (27.3) | 229 (22.8) |
| Not Hispanic or Latino | 769 (77.3) | 8 (72.7) | 777 (77.2) |
| Race, n (%) | |||
| Caucasian | 561 (56.4) | 10 (90.9) | 571 (56.8) |
| African–American | 357 (35.9) | 1 (9.1) | 358 (35.6) |
| Asian | 20 (2.0) | 0 | 20 (2.0) |
| American Indian or Alaska Native | 13 (1.3) | 0 | 13 (1.3) |
| Native Hawaiian or other Pacific | 5 (0.5) | 0 | 5 (0.5) |
| Islander | 39 (3.9) | 0 | 39 (3.9) |
| Other | |||
| Highest level of education | |||
| No high-school diploma | 35 (3.5) | 1 (9.1) | 36 (3.6) |
| High-school diploma or equivalent | 233 (23.4) | 2 (18.2) | 235 (23.4) |
| Some college education | 408 (41.0) | 4 (36.4) | 412 (41.0) |
| College degree or higher | 319 (32.1) | 4 (36.4) | 323 (32.1) |
| Bodyweight, kg | |||
| Mean ± SD | – | – | 76.7 ± 21.92 |
| Median (min, max) | – | – | 72 (39, 206) |
| BMI, n (%) | |||
| ≤ 25 kg/m2 | 387 (38.9) | 1 (9.1) | 388 (38.6) |
| > 25–<30 kg/m2 | 256 (25.7) | 8 (72.7) | 264 (26.2) |
| < 30 kg/m2 | 643 (64.6) | 9 (81.8) | 652 (64.8) |
| ≥ 30 kg/m2 | 352 (35.4) | 2 (18.2) | 354 (35.2) |
| ≥ 35 kg/m2 | 182 (18.3) | – | 182 (18.1) |
| ≥ 40 kg/m2 | 84 (8.4) | – | 84 (8.3) |
| Blood pressure (SBP/DBP) | |||
| < 130/85 mmHg, n (%) | 876 (88.0) | 11 (100.0) | 887 (88.2) |
| ≥ 130/85 mmHg, n (%) | 119 (12.0) | 0 | 119 (11.8) |
| Previous exposure to hormonal contraceptives, n (%) | |||
| Naïve user | – | – | 209 (20.8) |
| Non-switching previous user | |||
| ≥ 3 months | 463 (46.0) | ||
| < 3 months | 70 (7.0) | ||
| Switcher | 264 (26.2) | ||
| VTE risk factors, n (%) | |||
| Family history of thromboembolic illness | – | – | |
| Yes | 12 (1.2) | ||
| No | 993 (98.8) | ||
| Missing | 1 | ||
| Current smoker ≥ 35 years or non-smoker ≥ 40 years | |||
| Yes | – | – | 51 (5.1) |
| No | 955 (94.9) | ||
| BMI ≥ 30 kg/m2 | |||
| Yes | – | – | 353 (35.1) |
| No | 653 (64.9) | ||
| Number of VTE risk factorsa | |||
| No risk factors | – | – | 611 (60.8) |
| 1 risk factor | 367 (36.5) | ||
| 2 risk factors | 27 (2.7) | ||
| ≥ 3 risk factors | 0 |
a
Risk factors: family history of thromboembolic illness, current smoker ≥ 35 years or non-smoker ≥ 40 years or BMI ≥ 30 kg/m2. Missing data for 1 participant.