Table 3.
Statistical comparison of pharmacokinetic parameters of ethinyl estradiol, norelgestromin, and norgestrel following administration of COC alone or COC and erenumab
| LS geometric meana | Ratio of test/referenceb (90% confidence interval) | ||
|---|---|---|---|
| COC and erenumab (test), n = 22 | COC alone (reference), n = 25 | ||
| Ethinyl estradiol | |||
| Cmax (pg/mL) | 129.1 | 124.3 | 1.04 (0.88–1.22) |
| AUCtau (h·pg/mL) | 978.6 | 957.0 | 1.02 (0.91–1.14) |
| Norelgestromin | |||
| Cmax (pg/mL) | 1783.7 | 1698.0 | 1.05 (0.90–1.23) |
| AUCtau (h·pg/mL) | 16,514.0 | 16,133.4 | 1.02 (0.94–1.12) |
| Norgestrel | |||
| Cmax (pg/mL) | 2647.1 | 2500.7 | 1.06 (0.97–1.16) |
| AUCtau (h·pg/mL) | 47,811.5 | 46,460.5 | 1.03 (0.96–1.10) |
Data based on pharmacokinetics analysis set. n represents the number of subjects with recorded observations
AUCtau area under the plasma concentration–time curve from time 0 to 24 h, Cmax maximum observed plasma concentration, COC combined oral contraceptive, LS least squares
aLS geometric mean from the SAS PROC MIXED procedure (SAS Institute Inc., Cary, NC, USA; version 9.4)
bThe ratio (coadministration of COC and erenumab [test]/COC alone [reference]) and confidence intervals are based on natural log scale data converted back to the original scale