{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T12:59:46Z","timestamp":1791809986462,"version":"4.3.4"},"reference-count":31,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,1,14]],"date-time":"2015-01-14T00:00:00Z","timestamp":1421193600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2015,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>\n                      The effect of semaglutide, a once\u2010weekly human glucagon\u2010like peptide\u20101 (GLP\u20101) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n\u2009=\u200943) on diet\/exercise\u2009\u00b1\u2009metformin received ethinylestradiol (0.03\u2009mg)\/levonorgestrel (0.15\u2009mg) once daily for 8 days before (semaglutide\u2010free) and during (steady\u2010state 1.0\u2009mg) semaglutide treatment (subcutaneous once weekly; dose escalation: 0.25\u2009mg 4 weeks; 0.5\u2009mg 4 weeks; 1.0\u2009mg 5 weeks). Bioequivalence of oral contraceptives was established if 90%CI for the ratio of pharmacokinetic parameters during semaglutide steady\u2010state and semaglutide\u2010free periods was within prespecified limits (0.80\u20131.25). The bioequivalence criterion was met for ethinylestradiol area under the curve (AUC\n                      <jats:sub>0\u201324\u2009h<\/jats:sub>\n                      ) for semaglutide steady\u2010state\/semaglutide\u2010free; 1.11 (1.06\u20131.15). AUC\n                      <jats:sub>0\u201324\u2009h<\/jats:sub>\n                      was 20% higher for levonorgestrel at semaglutide steady\u2010state vs. semaglutide\u2010free (1.20 [1.15\u20131.26]). C\n                      <jats:sub>max<\/jats:sub>\n                      was within bioequivalence criterion for both contraceptives. Reductions (mean\u2009\u00b1\u2009SD) in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      (\u20131.1\u2009\u00b1\u20090.6%) and weight (\u20134.3\u2009\u00b1\u20093.1\u2009kg) were observed. Semaglutide pharmacokinetics were compatible with once\u2010weekly dosing; the semaglutide dose and dose\u2010escalation regimen were well tolerated. Adverse events, mainly gastrointestinal, were mild to moderate in severity. Asymptomatic increases in mean amylase and lipase were observed. Three subjects had elevated alanine aminotransferase levels \u22653x the upper limit of normal during semaglutide\/oral contraceptive coadministration, which were reported as adverse events, but resolved during follow\u2010up. Semaglutide did not reduce the bioavailability of ethinylestradiol and levonorgestrel.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcph.443","type":"journal-article","created":{"date-parts":[[2014,12,8]],"date-time":"2014-12-08T20:39:28Z","timestamp":1418071168000},"page":"497-504","source":"Crossref","is-referenced-by-count":168,"title":["Semaglutide, a once\u2010weekly human GLP\u20101 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol\/levonorgestrel"],"prefix":"10.1002","volume":"55","author":[{"given":"Christoph","family":"Kapitza","sequence":"first","affiliation":[{"name":"Profil Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leszek","family":"Nosek","sequence":"additional","affiliation":[{"name":"Profil Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lene","family":"Jensen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helle","family":"Hartvig","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine B.","family":"Jensen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Flint","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,1,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69705-5"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI990"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ijo.0800818"},{"issue":"1","key":"e_1_2_7_5_1","first-page":"327","article-title":"Gastric emptying, glucose responses, and insulin secretion after a liquid test meal: effects of exogenous glucagon\u2010like peptide\u20101 (GLP\u20101)\u2010(7\u201336) amide in type 2 (noninsulin\u2010dependent) diabetic patients","volume":"81","author":"Willms B","year":"1996","journal-title":"J Clin Endocrinol Metab"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1900\/RDS.2008.5.73"},{"issue":"7","key":"e_1_2_7_7_1","first-page":"S20","article-title":"Novel incretin\u2010based agents and practical regimens to meet needs and treatment goals of patients with type 2 diabetes mellitus","volume":"111","author":"Garber AJ","year":"2011","journal-title":"J Am Osteopath Assoc"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1445-5994.2011.02439.x"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13300-011-0002-3"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.2147\/VHRM.S4039"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3148"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/ijo.2013.120"},{"issue":"1","key":"e_1_2_7_13_1","first-page":"S7(2\u2010OP)","article-title":"The once\u2010weekly human GLP\u20101 analogue semaglutide provides significant reductions in HbA1c and body weight in patients with type 2 diabetes","volume":"55","author":"Nauck MA","year":"2012","journal-title":"Diabetologia"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/db13-1087"},{"key":"e_1_2_7_15_1","unstructured":"Novo Nordisk.;1; Data on file 2013."},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/tre.107"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270010389471"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1Q379"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6904-12-8"},{"key":"e_1_2_7_20_1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 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