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The absence of intersubject transfer of 17β‐estradiol gel between dosed and non‐dosed post‐menopausal women after direct skin‐to‐skin contact
Author(s) -
ZumBrunnen T. L.,
Meuwsen I.,
Vries M. H.,
Brennan J. J.
Publication year - 2004
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2003.11.217
Subject(s) - estrone , estrone sulfate , medicine , cmax , urology , crossover study , pharmacokinetics , estrogen , placebo , pathology , alternative medicine
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.2003.11.217Baseline Post‐ContactAUC(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) CmaxE2 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)