Table 4. Geometric mean (CV %) PK parameters for EE after application of the EE/GSD patch and the EE/NGMN patch, by application site in study 2. Parameters were estimated using the population PK model EE 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).
| Application site | Parameter | Unit | EE/GSD patch* | 0.6 mg EE/6 mg NGMN patch | 0.6 mg EE/6 mg NGMN patch: EE/GSD patch |
|---|---|---|---|---|---|
| Abdomen | n = 37 | n = 33 | |||
| AUC0–168,ss | ng×h/L | 4,971 (26.1%) | 12,739 (33.4%) | 2.6 | |
| Cav,ss | ng/L | 29.6 (26.1%) | 75.8 (33.4%) | 2.6 | |
| Cmax,ss | ng/L | 43.7 (18.2%) | 117 (23.0%) | 2.7 | |
| Arm | n = 37 | n = 41 | |||
| AUC0–168,ss | ng×h/L | 6,780 (30.8%) | 13,839 (24.4%) | 2.0 | |
| Cav,ss | ng/L | 40.4 (30.8%) | 82.4 (24.4%) | 2.0 | |
| Cmax,ss | ng/L | 60.4 (21.5%) | 123 (16.9%) | 2.0 | |
| Buttocks | n = 42 | n = 53 | |||
| AUC0–168,ss | ng×h/L | 6,845 (28.2%) | 15,335 (24.3%) | 2.2 | |
| Cav,ss | ng/L | 40.7 (28.2%) | 91.3 (24.3%) | 2.2 | |
| Cmax,ss | ng/L | 60.7 (19.6%) | 132 (17.3%) | 2.2 |
*EE/GSD patch: 0.55 mg EE/2.1 mg GSD. 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; CV = coefficient of variation; EE = ethinyl estradiol; GSD = gestodene; NGMN = norelgestromin; PK = pharmacokinetic.