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Serum Estradiol and Estrone Levels During 3 Weeks of Alternate-Site and Same-Site Applications of a Once-A-Week
Lester I. Harrison1, Dianna J. Riedel, Stephanie J. Reynolds
13M Pharmaceuticals, Departments of Pharmacokinetics and Drug Metabolism, Clinical Research, Statistical Data Services and Analytical Research and Development, St. Paul, MN, USA.
Abstract:
This open-label, randomized crossover trial was conducted in healthy postmenopausal women to characterize the serum estradiol and estrone profiles from a once-a-week transdermal estradiol patch applied repeatedly to the same site or to alternate sites on the abdomen over a 3-week period. Similar mean serum estradiol and estrone profiles and circulating estradiol:estrone ratios of approximately 1.0 were observed for both patch application regimes. Repeated application to the same or alternate sites did not result in an accumulation of exogenous estradiol or in a statistically significant increase in application-site reactions. Although the once-a-week transdermal estradiol patch should be applied to alternate sites to reduce the likelihood of dermatologic reactions, accidental application site overlap should not result in an increase in serum estradiol and estrone concentrations.
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