{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:37:41Z","timestamp":1789580261483,"version":"build-2803163510"},"reference-count":17,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,7,14]],"date-time":"2024-07-14T00:00:00Z","timestamp":1720915200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007804","name":"Oregon Clinical and Translational Research Institute","doi-asserted-by":"publisher","award":["UL1TR002369"],"award-info":[{"award-number":["UL1TR002369"]}],"id":[{"id":"10.13039\/100007804","id-type":"DOI","asserted-by":"publisher"}]},{"name":"NIH","award":["P51OD011092"],"award-info":[{"award-number":["P51OD011092"]}]},{"name":"NIH","award":["R01 HD089957"],"award-info":[{"award-number":["R01 HD089957"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Sex Reprod Health"],"accepted":{"date-parts":[[2024,6,20]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To determine whether increasing the dose of ulipristal acetate (UPA)-containing emergency contraception (EC) improves pharmacodynamic outcomes in individuals with obesity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study design<\/jats:title>\n                  <jats:p>We enrolled healthy, regularly-cycling, confirmed ovulatory, reproductive-age individuals with body mass index (BMI) &gt;30\u2009kg\/m<jats:sup>2<\/jats:sup> and weight &gt;80\u2009kg in a randomised crossover study. We monitored participants with transvaginal ultrasound and blood sampling for progesterone, luteinising hormone (LH), and estradiol every other day until a dominant follicle measuring &gt;15\u2009mm was visualised. At that point, participants received either oral UPA EC 30\u2009mg or 60\u2009mg and returned for daily monitoring up to 7\u2009days. After a no treatment washout cycle, participants returned for a second monitored cycle and received the other UPA dose. Our primary outcome was the proportion of subjects with no follicle rupture 5\u2009days post-dosing (yes\/no). For reference, we also enrolled a control group with BMI &lt;25\u2009kg\/m<jats:sup>2<\/jats:sup> and weight &lt;80\u2009kg who received UPA EC 30\u2009mg during a single cycle. We also obtained blood samples for pharmacokinetic parameters for UPA and its active metabolite, <jats:italic>N<\/jats:italic>-monodemethyl-UPA (NDM-UPA) as an optional substudy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled a total of 52 participants with BMI &gt;30\u2009kg\/m<jats:sup>2<\/jats:sup> and 12 controls, with the following cycles completed: 12 controls, 49 UPA 30\u2009mg, and 46 UPA 60\u2009mg. The entire cohort demographics were a mean (SD) age of 29.8 (3.4) years and BMI by group: controls 22.5 (1.4) kg\/m<jats:sup>2<\/jats:sup>, group 1 37.9 (6.7) kg\/m<jats:sup>2<\/jats:sup>, and group 2 39.3 (5.4) kg\/m<jats:sup>2<\/jats:sup>. All 12 (100%) of controls had a delay of at least 5\u2009days for follicle rupture. Among the high BMI group, dosing groups (UPA EC 30\u2009mg vs 60\u2009mg) were similar in the proportion of cycles without follicle rupture over 5\u2009days post-UPA dosing (UPA 30\u2009mg: 47\/49 (96%), UPA 60\u2009mg: 42\/46 (91%), Fisher\u2019s exact test p=0.43). However, after excluding cycles where dosing occurred too late (after LH surge), a delay of at least 5\u2009days occurred in all participants at both doses. The 60\u2009mg UPA dose resulted in a twofold increase in maximum observed concentration and the area under the curve of both UPA and NDM-UPA levels compared with 30\u2009mg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>A standard 30\u2009mg dose of UPA is sufficient to delay ovulation regardless of BMI or weight. Results of our study do not support dose adjustment for body size.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjsrh-2024-202401","type":"journal-article","created":{"date-parts":[[2024,7,14]],"date-time":"2024-07-14T13:20:15Z","timestamp":1720963215000},"page":"27-35","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Double dosing ulipristal acetate emergency contraception for individuals with obesity: a randomised crossover trial"],"prefix":"10.1136","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5040-7288","authenticated-orcid":false,"given":"Alison","family":"Edelman","sequence":"first","affiliation":[{"name":"Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon D","family":"Hennebold","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon, USA"},{"name":"Division of Reproductive & Developmental Sciences, Oregon Primate National Research Center, Beaverton, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kise","family":"Bond","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeong Y","family":"Lim","sequence":"additional","affiliation":[{"name":"Biostatistics Shared Resource, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Cherala","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Nurix Therapeutics, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven W","family":"Blue","sequence":"additional","affiliation":[{"name":"Endocrine Technologies Core, Oregon Primate National Research Center, Beaverton, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn P","family":"Kraft","sequence":"additional","affiliation":[{"name":"Endocrine Technologies Core, Oregon Primate National Research Center, Beaverton, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3383-9297","authenticated-orcid":false,"given":"David W","family":"Erikson","sequence":"additional","affiliation":[{"name":"Endocrine Technologies Core, Oregon Primate National Research Center, Beaverton, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Archer","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Department of OB\/GYN, Eastern Virginia Medical School, Norfolk, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffery","family":"Jensen","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,7,14]]},"reference":[{"key":"2025090511415963000_51.1.27.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)05145-9"},{"key":"2025090511415963000_51.1.27.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2013.05.010"},{"key":"2025090511415963000_51.1.27.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)11767-3"},{"key":"2025090511415963000_51.1.27.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2004.05.007"},{"key":"2025090511415963000_51.1.27.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2011.02.009"},{"key":"2025090511415963000_51.1.27.6","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.contraception.2016.03.006","article-title":"Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing","volume":"94","author":"Edelman","year":"2016","journal-title":"Contraception"},{"key":"2025090511415963000_51.1.27.7","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1097\/AOG.0000000000004717","article-title":"Double dosing levonorgestrel-based emergency contraception for individuals with obesity: a randomized controlled trial","volume":"140","author":"Edelman","year":"2022","journal-title":"Obstet Gynecol"},{"key":"2025090511415963000_51.1.27.8","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1016\/j.contraception.2017.01.004","article-title":"Pharmacokinetics of levonorgestrel and ulipristal acetate emergency contraception in women with normal and obese body mass index","volume":"95","author":"Praditpan","year":"2017","journal-title":"Contraception"},{"key":"2025090511415963000_51.1.27.9","first-page":"325","article-title":"Ulipristal acetate (ella): a selective progesterone receptor modulator for emergency contraception","volume":"36","author":"Kim","year":"2011","journal-title":"P T"},{"key":"2025090511415963000_51.1.27.10","unstructured":"US Food and Drug Administration . FDA ella prescribing information. Available: http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/022474s007lbl.pdf [Accessed 5 Jan 2016]."},{"key":"2025090511415963000_51.1.27.11","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.12065"},{"key":"2025090511415963000_51.1.27.12","unstructured":"Eurpean Medicines Agency . CHMP assessment report for ellaone. Available: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Public_assessment_report\/human\/001027\/WC500023673.pdf [Accessed 5 Jan 2016]."},{"key":"2025090511415963000_51.1.27.13","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dev241"},{"key":"2025090511415963000_51.1.27.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2012.07.004"},{"key":"2025090511415963000_51.1.27.15","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1016\/j.contraception.2018.08.003","article-title":"Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: a prospective cohort study","volume":"98","author":"Edelman","year":"2018","journal-title":"Contraception"},{"key":"2025090511415963000_51.1.27.16","first-page":"1","article-title":"Anthropometric reference data for children and adults: United States, 2015-2018","volume":"3","author":"Fryar","year":"2021","journal-title":"Vital Health Stat"},{"key":"2025090511415963000_51.1.27.17","doi-asserted-by":"crossref","first-page":"605","DOI":"10.1016\/j.contraception.2016.05.002","article-title":"Safety and effectiveness data for emergency contraceptive pills among women with obesity: a systematic review","volume":"94","author":"Jatlaoui","year":"2016","journal-title":"Contraception"}],"container-title":["BMJ Sexual &amp; Reproductive Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjsrh-2024-202401","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T18:59:20Z","timestamp":1757098760000},"score":1,"resource":{"primary":{"URL":"https:\/\/jfprhc.bmj.com\/lookup\/doi\/10.1136\/bmjsrh-2024-202401"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,14]]},"references-count":17,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,1,6]]},"published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.1136\/bmjsrh-2024-202401"],"URL":"https:\/\/doi.org\/10.1136\/bmjsrh-2024-202401","relation":{},"ISSN":["2515-1991","2515-2009"],"issn-type":[{"value":"2515-1991","type":"print"},{"value":"2515-2009","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,14]]}}}