{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T07:17:47Z","timestamp":1696576667179},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,12,30]],"date-time":"2015-12-30T00:00:00Z","timestamp":1451433600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The aim of this work was to explore the major design features of drug\u2013drug interaction trials between antiviral medications (AVs) and oral contraceptives (OCs). Information on these trials (n = 27) was collected from approved drug labels and clinical pharmacology reviews conducted by the U.S. Food and Drug Administration. The primary objective of all trials was to evaluate changes in OC exposure following the coadministration of AVs. In addition, an evaluation of potential pharmacodynamic interaction was performed in 10 of these trials. Twenty\u2010two trials were open label with a fixed\u2010sequence design, and 5 trials used a double\u2010blind crossover design. The trials were conducted using one, two, or three 28\u2010day ovulatory cycles in 10, 8, and 9 trials, respectively. Only 1 trial enrolled HIV\u2010infected women. The median number of women in a trial was 20 (range, 12 to 52). Norethindrone\/ethinyl estradiol (EE) combination was the most commonly used OC (n = 16, 59%) followed by norgestimate\/EE (n = 9, 33%). Labeling recommendations were based on exposure changes in 25 cases and on safety observations in the trial in 2 cases. In conclusion, a wide variety of trial designs was used, and there is no preferred design. The answer to the exposure question can be achieved using multiple designs.<\/jats:p>","DOI":"10.1002\/jcph.637","type":"journal-article","created":{"date-parts":[[2015,9,18]],"date-time":"2015-09-18T07:04:55Z","timestamp":1442559895000},"page":"541-547","source":"Crossref","is-referenced-by-count":3,"title":["Design Features of Drug\u2013Drug Interaction Trials Between Antivirals and Oral Contraceptives"],"prefix":"10.1002","volume":"56","author":[{"given":"Ruben C.","family":"Ayala","sequence":"first","affiliation":[{"name":"Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikram","family":"Arya","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Islam R.","family":"Younis","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,12,30]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"UNAIDS report on the global AIDS epidemic","author":"Joint United Nations Program on HIV\/AIDS (UNAIDS)","year":"2012"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003258669"},{"key":"e_1_2_6_4_1","volume-title":"Women and Health: Today's Evidence Tomorrow's Agenda","author":"World Health Organization","year":"2009"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.5009\/gnl.2009.3.3.145"},{"key":"e_1_2_6_6_1","first-page":"1","article-title":"Recommendations for use of antiretroviral drugs in pregnant HIV\u20101\u2010infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States","author":"Panel on Treatment of HIV\u2010Infected Pregnant Women and Prevention of Perinatal Transmission","year":"2012","journal-title":"Federal Register"},{"key":"e_1_2_6_7_1","unstructured":"JonesJ MosherW DanielsK.Current Contraceptive Use in the United States 2006\u20132010 and Changes in Patterns of Use Since 1995. 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