Table 1.
Baseline demographics and pharmacokinetic parameters (mean ± standard deviation) of LNG and EE prior to randomization to study arms.
| CC group | ID group | |||
|---|---|---|---|---|
| Age | 30 (SD 4) | 27 (SD 4) | ||
| Race Non-Hispanic, Caucasian Other |
14 3 |
15 0 |
||
| Ever pregnant? (yes)** | 12 | 3 | ||
| BMI | 38.0 kg/m2 (SD 5.1) | 41.1 kg/m2 (SD 7.6) | ||
| % body fat | 45.5 (SD 3.5) | 47.3 (SD 4.1) | ||
| PK Parameters | LNG | EE | LNG | EE |
| Tmax (hr) | 1.86 ± 0.85 | 1.91 ± 1.10 | 2.28 ± 1.39 | 1.61 ± 1.10 |
| Cmax (ng/mL) | 3.82 ± 1.28 | 0.12 ± 0.04 | 3.13 ± 0.87 | 0.10 ± 0.03 |
| AUC(0-∞) (hr*ng/mL) | 267 ± 115 | 10.4 ± 4.33 | 199 ± 75.0 | 10.6 ± 4.49 |
| T1/2 (hr) | 70.7 ± 50.4 | 158 ± 81.1 | 59.4 ± 26.6 | 185 ± 99.6 |
| Vd/F (L) | 43.5 ± 29.2 | 454 ± 186 | 46.7 ± 23.4 | 482 ± 121 |
| CL/F (L/hr) | 0.47 ± 0.28 | 2.29 ± 0.99 | 0.57 ± 0.19 | 2.17 ± 0.85 |
**
denotes p value < 0.05