Ortho Evra - Clinical Pharmacology

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Analyte Parameter Cycle 1 Cycle 3 Cycle 3 Cycle 3

Week 1 Week 1 Week 2 Week 3

Norelgestromin Css a 0.70 (0.28) 0.70 (0.29) 0.80 (0.23) 0.70 (0.32)

AUC0-168

b 107 (44.2) 105 (45.5) 132 (57.1) 120 (52.8)

t 1/2c nc nc nc 32.1 (12.9)

EE Css d 46.4 (17.9) 47.6 (17.3) 59.0 (25.1) 49.6 (27.0)

AUC0-168

e 6796 (2673) 7160 (2893) 10054 (4205) 8840 (5176)

t 1/2c nc nc nc 21.0 (9.07)

ang/mL

bng·h/mL

c h

dpg/mL

epg·h/mL

nc = not calculated

Figure 1: Mean Norelgestromin Serum Concentrations (ng/mL) in Healthy Female Volunteers Following Application of ORTHO EVRA® on the Buttock for Three Consecutive Cycles (Dotted horizontal lines indicate the

reference range. Dotted vertical arrow indicates time of patch removal.)

Figure 2: Mean Ethinyl Estradiol Serum Concentrations (pg/mL) in Healthy Female Volunteers Following Application of ORTHO EVRA® on the Buttock for Three Consecutive Cycles (Dotted horizontal lines indicate the reference range. Dotted vertical arrow indicates time of patch removal.)

Results from a study of consecutive ORTHO EVRA® wear for 7 days and 10 days indicated that serum concentrations of norelgestromin and EE dropped slightly during the first 6 hours after the patch replacement, still

stayed within the reference range and recovered within 12 hours. Target Css of norelgestromin and EE were maintained during 2 days of extended wear of ORTHO EVRA®.

Figure 3: Mean (SD) Norelgestromin Serum Concentrations (ng/mL) Following Application of ORTHO EVRA®

to the Abdomen for 7 Days and 10 Days (Dotted horizontal lines indicate the reference range. Solid vertical arrows indicate actual time of patch removal. Dotted vertical arrow indicates theoretical time of patch removal under normal use.)

Figure 4: Mean (SD) EE Serum Concentrations (pg/mL) Following Application of ORTHO EVRA® to Abdomen for 7 Days and 10 Days (Dotted horizontal lines indicate reference range. Solid vertical arrows indicate actual time of patch removal. Dotted vertical arrow indicates theoretical time of patch removal under normal use.)