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- W2124761975 abstract "Purpose To evaluate the extent of intersubject transfer and subsequent exposure to estradiol (E2), estrone (E1) and estrone sulfate (E1S) in non-dosed post-menopausal women after direct skin-to-skin contact with post-menopausal women dosed with 0.06% 17β-estradiol gel (EGEL). Methods: This was a single-center, randomized, open-label, two-period, crossover, multiple-dose study to evaluate the extent of transfer of EGEL from 24 post-menopausal women administered 1.25g of EGEL daily for 14 days to an additional 24 post-menopausal women by direct skin-to-skin contact. Blood samples for determination of PK parameters were obtained from non-dosed subjects over a 24-hour interval at baseline and Day 14. Serum levels of E2, E1 and E1S were determined by RIA methods. Paired t-tests were used to compare baseline values of E2, E1 and E1S to values obtained after skin-to-skin contact. Results Mean(SD) PK parameters for E2, E1 and E1S after skin-to-skin contact were not statistically different from baseline values.(see Table 1) Conclusion Intersubject transfer of EGEL, as determined by AUC and Cmax, from dosed to non-dosed subjects and subsequent absorption of E2 is negligible and clinically insignificant. Clinical Pharmacology & Therapeutics (2004) 75, P57–P57; doi: 10.1016/j.clpt.2003.11.217 Baseline Post-Contact AUC(0–24) E2 pg*hr/mL 126.57 (61.79) 27.52 (66.60) E1 pg*hr/mL 510.46 (262.69) 529.00 (225.27) E1S ng*hr/mL 11.45 (4.01) 11.44 (4.29) Cmax E2 pg/mL 7.38 (3.55) 7.85 (3.28) E1 pg/mL 29.75 (13.81) 32.21 (10.19) E1S ng/mL 0.59 (0.21) 0.58 (0.21)" @default.
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- W2124761975 date "2004-02-01" @default.
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- W2124761975 title "The absence of intersubject transfer of 17β-estradiol gel between dosed and non-dosed post-menopausal women after direct skin-to-skin contact" @default.
- W2124761975 doi "https://doi.org/10.1016/j.clpt.2003.11.217" @default.
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