TY - JOUR
T1 - Pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and an oral contraceptive
AU - Devineni, Damayanthi
AU - Skee, Donna
AU - Vaccaro, Nicole
AU - Massarella, Joseph
AU - Janssens, Luc
AU - LaGuardia, Katherine D.
AU - Leung, Albert T.
PY - 2007/4
Y1 - 2007/4
N2 - This open-label, randomized, 2-way crossover study characterized the pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and a norgestimatecontaining oral contraceptive. Healthy women (n = 34) applied a patch once weekly for 3 consecutive weeks during each of 2 cycles and received an oral contraceptive for 21 consecutive days during each of 2 cycles. Plasma concentrations of norelgestromin and ethinyl estradiol peaked and waned after daily oral contraceptive administration, whereas they rose and reached steady-state levels after first patch application. Norelgestromin exposure was similar; ethinyl estradiol exposure was higher for the patch than oral contraceptive. Hepatic estrogenic activity, assessed by hepatic globulin synthesis, was similar for corticosteroid-binding globulin and corticosteroid-binding globulin-binding capacity and higher for sex hormone-binding globulin for the patch versus oral contraceptive. The clinical significance of the differences in pharmacokinetic and pharmacodynamic profiles between the patch and oral contraceptive is not fully known. No serious adverse events or discontinuations due to adverse events were recorded.
AB - This open-label, randomized, 2-way crossover study characterized the pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and a norgestimatecontaining oral contraceptive. Healthy women (n = 34) applied a patch once weekly for 3 consecutive weeks during each of 2 cycles and received an oral contraceptive for 21 consecutive days during each of 2 cycles. Plasma concentrations of norelgestromin and ethinyl estradiol peaked and waned after daily oral contraceptive administration, whereas they rose and reached steady-state levels after first patch application. Norelgestromin exposure was similar; ethinyl estradiol exposure was higher for the patch than oral contraceptive. Hepatic estrogenic activity, assessed by hepatic globulin synthesis, was similar for corticosteroid-binding globulin and corticosteroid-binding globulin-binding capacity and higher for sex hormone-binding globulin for the patch versus oral contraceptive. The clinical significance of the differences in pharmacokinetic and pharmacodynamic profiles between the patch and oral contraceptive is not fully known. No serious adverse events or discontinuations due to adverse events were recorded.
KW - Ethinyl estradiol
KW - Norelgestromin
KW - Oral contraceptive
KW - Pharmacokinetics
KW - Transdermal contraceptive patch
UR - http://www.scopus.com/inward/record.url?scp=33947496869&partnerID=8YFLogxK
U2 - 10.1177/0091270006297919
DO - 10.1177/0091270006297919
M3 - Article
C2 - 17389559
AN - SCOPUS:33947496869
SN - 0091-2700
VL - 47
SP - 497
EP - 509
JO - Journal of Clinical Pharmacology
JF - Journal of Clinical Pharmacology
IS - 4
ER -