Table 5. Geometric mean (CV %) PK parameters for EE, SHBG, and total and unbound GSD for the EE/GSD patch (0.55 mg EE/2.1 mg GSD) per application site in study 2, estimated using the population PK model EE/SHBG/GSD for the third week of treatment cycle 3 (also representative of treatment cycles 1 and 7 because steady state was effectively achieved by week 3 in all treatment cycles).
| Analyte | Parameter | Unit | Abdomen (n = 37) |
Arm (n = 37) |
Buttocks (n = 42) |
|---|---|---|---|---|---|
| EE | AUC0‒168,ss | (ng×h)/L | 4,991 (25.5%) | 6,746 (29.8%) | 6,818 (28.3%) |
| Cav,ss | ng/L | 29.7 (25.5%) | 40.2 (29.8%) | 40.6 (28.3%) | |
| Cmax,ss | ng/L | 43.6 (18.0%) | 59.8 (21.0%) | 60.2 (19.8%) | |
| GSD total | AUC0‒168,ss | (µg×h)/L | 897 (38.3%) | 1005 (35.6%) | 947 (45.9%) |
| Cav,ss | µg/L | 5.34 (38.3%) | 5.98 (35.6%) | 5.64 (45.9%) | |
| Cmax,ss | µg/L | 6.54 (32.8%) | 7.19 (30.7%) | 6.83 (38.8%) | |
| GSD unbound | AUC0‒168,ss | (µg×h)/L | 5.83 (23.9%) | 5.92 (25.1%) | 5.88 (27.6%) |
| Cav,ss | µg/L | 0.0347 (23.9%) | 0.0353 (25.1%) | 0.0350 (27.6%) | |
| Cmax,ss | µg/L | 0.0434 (18.3%) | 0.0434 (20.2%) | 0.0435 (20.6%) | |
| SHBG | Cav,ss | nmol/L | 237 (35.6%) | 268 (38.1%) | 251 (38.3%) |
AUC0–168,ss = area under the concentration-time curve at steady state; Cav,ss = average serum concentration at steady state; Cmax,ss = maximum serum concentration at steady state; EE = ethinyl estradiol; GSD = gestodene; PK = pharmacokinetic; SHBG = sex hormone-binding globulin.