Table 3.
Statistical analysis for pharmacokinetic parameters of relugolix after administration of relugolix alone or relugolix plus E2/NETA in healthy adult premenopausal women for 6 weeks
| Pharmacokinetic parameter | N | Geometric mean | CVW (%) | Geometric mean ratioa | 90% CI |
|---|---|---|---|---|---|
| Week 6 | |||||
| AUC0–24 (ng*h/mL) | |||||
| Relugolix alone | 25 | 116 | |||
| Coadministration (relugolix + E2/NETA) | 22 | 128 | 24.6 | 1.10 | (0.84, 1.44) |
| Cmax (ng/mL) | |||||
| Relugolix alone | 25 | 17.6 | |||
| Coadministration (relugolix + E2/NETA) | 22 | 18.9 | 40.6 | 1.07 | (0.76, 1.51) |
AUC0–24 and Cmax parameters were analyzed on a natural log scale; only participants with evaluable parameter values in both Test and Reference treatments were included in the statistical analysis for AUC0–24 and Cmax
AUC area under the concentration–time curve, AUC0–24 AUC from time 0 to 24 h, CI confidence interval, Cmax maximum observed concentration, CVW within-subject coefficient of variation, E2 estradiol, h hour, n number of participants included in summary statistics, NETA norethindrone acetate
aRatio of geometric mean between Test (relugolix plus E2/NETA) and Reference (relugolix alone). From a mixed-effects model for the log-transformed parameter results with treatment as fixed effect and participant as a random effect