Table 2. Mean PK parameters for EE (upper table) and unbound GSD (lower table) in study 1.
| Treatment P* (n = 22) |
Treatment M†
(n = 22) |
Treatment E‡§
(n = 20) |
||
|---|---|---|---|---|
| PK parameter | Unit | Geometric mean (CV) | ||
| Cmax | ng/L | 37.5 (24.4%) | 59.6 (34.7%) | 37.8 (24.6%) |
| tmax (min, max) | h | 35.0 (12.0, 72.2) | 1.5 (0.5, 3.0) | 24.8 (11.9, 48.0) |
| AUC0–168/7 | ng×h/L | 648 (22.4%) | – | – |
| AUC0–24 | ng×h/L | – | 611 (30.6%) | – |
| t1/2 | h | 22.9 (20.1%)¶ | 17.6 (23.0%)# | 22.7 (20.3%)** |
| Cmin | ng/L | 17.9 (27.8%) | 12.9 (41.3%) | 15.6 (26.0%)†† |
| Cav | ng/L | 27.0 (22.4%) | 25.5 (30.6%) | 23.9 (23.5%)†† |
| AUC0–168 | ng×h/L | 4,533 (22.4%) | – | – |
| Treatment P* (n = 22) |
Treatment M†
(n = 22) |
Treatment E‡§
(n = 20) |
||
| PK parameter | Unit | Geometric mean (CV) | ||
| Cmax | µg/L | 0.0485 (34.6%) | 0.0844 (19.8%) | 0.0496 (35.9%) |
| tmax (min, max) | h | 36.1 (24.9, 71.8) | 1 (0.5, 1.5) | 35.7 (23.5, 95.6) |
| AUC0–168/7 | µg×h/L | 0.910 (32.7%) | – | – |
| AUC0–24 | µg×h/L | – | 1.11 (22.4%) | – |
| t1/2 | h | 27.1 (22.9%) | 25.2 (18.8%)†† | 27.3 (23.7%) |
| Cmin | µg/L | 0.0270 (32.9%) | 0.0317 (28.0%) | 0.0217 (32.5%) |
| Cav | µg/L | 0.0379 (32.7%) | 0.0462 (22.4%) | 0.0339 (30.6%) |
| AUC0–168 | µg×h/L | 6.37 (32.7%) | – | – |
*Treatment P: 0.55 mg EE + 2.1 mg GSD per patch (4 × 7-day wearing period); †treatment M: 0.02 mg EE + 0.075 mg GSD per pill (21-day, oral, once daily); ‡treatment E: 0.55 mg EE + 2.1 mg GSD per patch (2 × 7-day, followed by 1 × 10-day, wearing period); §Two women dropped out in period 3; ¶Data from 6 participants; #Data from 18 participants; **Data from 5 participants; ††Data from 20 participants. AUC0–168 = area under the concentration-time curve from time point of 4th (last) patch application until its removal 1 week later (treatment P); AUC0–168/7 = area under the concentration-time curve from time point of 4th (last) patch application until its removal 1 week later (treatment P) divided by 7; AUC0–24 = area under the concentration-time curve from time point of 21st (last) pill administration until 24 hours thereafter; Cav = average concentration obtained during last application interval; Cmax = maximum (peak) serum concentration obtained during last application interval; Cmin = minimum serum concentration during last application interval; CV = coefficient of variation; EE = ethinyl estradiol; GSD = gestodene; PK = pharmacokinetic; t1/2 = half-life associated with terminal slope; tmax = time to reach maximum (peak) concentration in serum obtained during last application interval.