Table 2.
Plasma pharmacokinetic parameters of ethinyl estradiol, norelgestromin, and norgestrel
| tmax (h) | Cmax (pg/mL) | AUCtau (h·pg/mL) | C24h (pg/mL) | |||||
|---|---|---|---|---|---|---|---|---|
| COC alone | COC and erenumab | COC alone | COC and erenumab | COC alone | COC and erenumab | COC alone | COC and erenumab | |
| Ethinyl estradiol | ||||||||
| n | 25 | 22 | 25 | 22 | 25 | 22 | 24 | 22 |
| Mean (SD) | NR | NR | 132 (46) | 143 (65) | 1010 (367) | 1060 (508) | 20.0 (11.1) | 21.0 (17.0) |
| Median (min–max) | 1.0 (1.0–2.0) | 1.0 (1.0–1.8) | NR | NR | NR | NR | NR | NR |
| CV% | NR | NR | 35.2 | 45.1 | 36.2 | 47.9 | 55.3 | 80.9 |
| Norelgestromin | ||||||||
| n | 25 | 22 | 25 | 22 | 25 | 22 | 24 | 22 |
| Mean (SD) | NR | NR | 1800 (641) | 1870 (553) | 16 800 (5120) | 16 900 (4200) | 407 (156) | 408 (122) |
| Median (min–max) | 1.0 (0.5–4.0) | 1.0 (0.5–4.0) | NR | NR | NR | NR | NR | NR |
| CV% | NR | NR | 35.6 | 29.6 | 30.5 | 24.8 | 38.3 | 30.0 |
| Norgestrel | ||||||||
| n | 25 | 22 | 25 | 22 | 25 | 22 | 24 | 22 |
| Mean (SD) | NR | NR | 2690 (887) | 2860 (927) | 50,700 (17,400) | 52,400 (17,400) | 1850 (593) | 1910 (720) |
| Median (min–max) | 1.5 (0.5–6.0) | 1.5 (1.0–6.0) | NR | NR | NR | NR | NR | NR |
| CV% | NR | NR | 33.0 | 32.5 | 34.3 | 33.2 | 32.0 | 37.8 |
The reported values of pharmacokinetic parameters (Cmax, C24h, and AUCtau) are arithmetic means and arithmetic SDs
AUCtau area under the plasma concentration–time curve from time 0 to 24 h, CV coefficient of variation, C24h drug concentration at 24 h postdose, Cmax maximum observed plasma concentration, COC combined oral contraceptive, max maximum, min minimum, NR not reported, tmax time to reach the maximum concentration (values are reported as median and range), SD standard deviation