Table 3. Mean daily area under the concentration-time curve (AUC) ratio and estimated daily dose delivery for EE and GSD after EE/GSD patch application (treatment P) compared with those for oral administration of a pill containing EE and GSD (treatment M).
PK parameter | Analyte | Treatments | Geometric mean AUC ratio of treatment P* vs. treatment M† | Lower 90% confidence limit | Upper 90% confidence limit | Geometric mean (range) estimated daily dose delivery µg |
---|---|---|---|---|---|---|
AUC‡ | GSD unbound | P vs. M | 0.820 | 0.760 | 0.885 | 61.5 (57.0 – 66.4) |
AUC‡ | EE | P vs. M | 1.06 | 0.964 | 1.16 | 21.2 (19.3 – 23.3) |
*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); ‡AUC0–168/7 for treatment P and AUC0–24 for treatment M. AUC0–168 = area under the concentration-time curve from time point of 4th (last) patch application until its removal 1 week later (treatment P); AUC0–24 = area under the concentration-time curve from time point of 21st (last) pill administration until 24 hours thereafter; EE = ethinyl estradiol; GSD = gestodene; PK = pharmacokinetic.