{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T05:51:46Z","timestamp":1780465906619,"version":"3.54.1"},"reference-count":12,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,8,7]],"date-time":"2017-08-07T00:00:00Z","timestamp":1502064000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Delayed\u2010release dimethyl fumarate (DMF) is an oral therapy for relapsing multiple sclerosis with anti\u2010inflammatory and neuroprotective properties. This 2\u2010period crossover study was conducted to evaluate the potential for drug\u2013drug interaction between DMF (240 mg twice daily) and a combined oral contraceptive (OC; norgestimate 250 \u03bcg, ethinyl estradiol 35 \u03bcg). Forty\u2010six healthy women were enrolled; 32 completed the study. After the lead\u2010in period (OC alone), 41 eligible participants were randomized 1:1 to sequence 1 (OC and DMF coadministration in period 1; OC alone in period 2) or sequence 2 (regimens reversed). Mean concentration profiles of plasma norelgestromin (primary metabolite of norgestimate) and ethinyl estradiol were superimposable following OC alone and OC coadministered with DMF, with 90% confidence intervals of geometric mean ratios for area under the plasma concentration\u2013time curve over the dosing interval and peak plasma concentration contained within the 0.8\u20131.25 range. Low serum progesterone levels during combined treatment confirmed suppression of ovulation. The pharmacokinetics of DMF (measured via its primary active metabolite, monomethyl fumarate) were consistent with historical data when DMF was administered alone. No new safety concerns were identified. These results suggest that norgestimate\/ethinyl estradiol\u2013based OCs may be used with DMF without dose modification.<\/jats:p>","DOI":"10.1002\/cpdd.377","type":"journal-article","created":{"date-parts":[[2017,8,7]],"date-time":"2017-08-07T16:52:45Z","timestamp":1502124765000},"page":"604-613","source":"Crossref","is-referenced-by-count":16,"title":["Evaluation of Potential Drug\u2013Drug Interaction Between Delayed\u2010Release Dimethyl Fumarate and a Commonly Used Oral Contraceptive (Norgestimate\/Ethinyl Estradiol) in Healthy Women"],"prefix":"10.1002","volume":"6","author":[{"given":"Bing","family":"Zhu","sequence":"first","affiliation":[{"name":"Biogen Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Nestorov","sequence":"additional","affiliation":[{"name":"Biogen Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guolin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Biogen Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Venkata","family":"Meka","sequence":"additional","affiliation":[{"name":"Biogen Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Leahy","sequence":"additional","affiliation":[{"name":"Covance Laboratories Inc. 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