{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T20:51:38Z","timestamp":1785790298866,"version":"3.56.0"},"reference-count":70,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T00:00:00Z","timestamp":1748736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["209589\/Z\/17\/Z"],"award-info":[{"award-number":["209589\/Z\/17\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100024021","name":"Reckitt Global Hygiene Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100024021","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["T32 HD52468"],"award-info":[{"award-number":["T32 HD52468"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["INV-045483"],"award-info":[{"award-number":["INV-045483"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["7200AA20CA00019"],"award-info":[{"award-number":["7200AA20CA00019"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill & Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1200867"],"award-info":[{"award-number":["OPP1200867"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000200","name":"US Agency for International Development","doi-asserted-by":"publisher","award":["7200AA20CA00016"],"award-info":[{"award-number":["7200AA20CA00016"]}],"id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005974","name":"Population Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005974","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","contraceptionjournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contraception"],"published-print":{"date-parts":[[2025,6]]},"DOI":"10.1016\/j.contraception.2025.110829","type":"journal-article","created":{"date-parts":[[2025,1,27]],"date-time":"2025-01-27T07:06:20Z","timestamp":1737961580000},"page":"110829","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":4,"special_numbering":"C","title":["Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials"],"prefix":"10.1016","volume":"146","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1721-805X","authenticated-orcid":false,"given":"Amelia C.L.","family":"Mackenzie","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Chung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Hoppes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne E.","family":"Burke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon L.","family":"Achilles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Leigh","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Bahamondes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana L.","family":"Blithe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Brache","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca L.","family":"Callahan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice F.","family":"Cartwright","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn B.H.","family":"Clancy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Colli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Cordova-Gomez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth C.","family":"Costenbader","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell D.","family":"Creinin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilary O.D.","family":"Critchley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo F.","family":"Doncel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laneta J.","family":"Dorflinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Edelman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Faustmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Gerlinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa B.","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Hennegan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e1ssia Raquel Teatin","family":"Juliato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon P.S.","family":"Kibira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Mansour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andres","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen A.","family":"Matteson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline A.","family":"Maybin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandria K.","family":"Mickler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kavita","family":"Nanda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chukwuemeka E.","family":"Nwachukwu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Funmilola M.","family":"OlaOlorun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J.","family":"Peine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chelsea B.","family":"Polis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina Sales","family":"Vieira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regine","family":"Sitruk-Ware","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer A.","family":"Smit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marsden","family":"Solomon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa M.","family":"Soule","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth E.","family":"Tolley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Vandeputte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.contraception.2025.110829_bib1","doi-asserted-by":"crossref","first-page":"49","DOI":"10.12688\/gatesopenres.13609.1","article-title":"Global research and learning agenda for building evidence on contraceptive-induced menstrual changes for research, product development, policies, and programs","volume":"6","author":"Hoppes","year":"2022","journal-title":"Gates Open Res"},{"key":"10.1016\/j.contraception.2025.110829_bib2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s12978-018-0561-0","article-title":"There might be blood: a scoping review on women\u2019s responses to contraceptive-induced menstrual bleeding changes","volume":"15","author":"Polis","year":"2018","journal-title":"Reprod Health"},{"key":"10.1016\/j.contraception.2025.110829_bib3","doi-asserted-by":"crossref","first-page":"417","DOI":"10.1080\/00224499.2015.1134425","article-title":"The sexual acceptability of contraception: reviewing the literature and building a new concept","volume":"53","author":"Higgins","year":"2016","journal-title":"J Sex Res"},{"key":"10.1016\/j.contraception.2025.110829_bib4","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1016\/j.contraception.2014.02.029","article-title":"Contraceptive sex acceptability: a commentary, synopsis and agenda for future research","volume":"90","author":"Higgins","year":"2014","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib5","doi-asserted-by":"crossref","first-page":"e1431","DOI":"10.1016\/S2214-109X(21)00318-1","article-title":"Expanding long-acting contraceptive options: a prospective cohort study of the hormonal intrauterine device, copper intrauterine device, and implants in Nigeria and Zambia","volume":"9","author":"Brunie","year":"2021","journal-title":"Lancet Glob Health"},{"key":"10.1016\/j.contraception.2025.110829_bib6","doi-asserted-by":"crossref","DOI":"10.9745\/GHSP-D-21-00789","article-title":"What have we learned? Implementation of a shared learning agenda and access strategy for the hormonal intrauterine device","volume":"10","author":"Rademacher","year":"2022","journal-title":"Glob Health Sci Pract"},{"key":"10.1016\/j.contraception.2025.110829_bib7","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1186\/s12913-017-2031-8","article-title":"Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework","volume":"17","author":"Sekhon","year":"2017","journal-title":"BMC Health Serv Res"},{"key":"10.1016\/j.contraception.2025.110829_bib8","first-page":"1","article-title":"Cultural aspects and mythologies around menstruation and abnormal uterine bleeding","author":"Tan","year":"2016","journal-title":"Best Pract Res Clin Obstet Gynaecol"},{"key":"10.1016\/j.contraception.2025.110829_bib9","series-title":"Speroff & Darney\u2019s Clinical Guide to Contraception","article-title":"The history of contraception","author":"Speroff","year":"2020"},{"key":"10.1016\/j.contraception.2025.110829_bib10","series-title":"Contraception: a concise history","author":"Drucker","year":"2020"},{"key":"10.1016\/j.contraception.2025.110829_bib11","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1093\/jhmas\/57.2.117","article-title":"Marks L. Women\u2019s trials: the approval of the first oral contraceptive pill in the United States and Great Britain","volume":"57","author":"Junod","year":"2002","journal-title":"J Hist Med Allied Sc"},{"key":"10.1016\/j.contraception.2025.110829_bib12","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1016\/j.contraception.2022.05.011","article-title":"Recommendations for standardization of bleeding data analyses in contraceptive studies","volume":"112","author":"Creinin","year":"2022","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib13","unstructured":"US Food and Drug Administration. Patient-focused drug development: collecting comprehensive and representative input: guidance for industry, food and drug administration staff, and other stakeholders. 2020. \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-collecting-comprehensive-and-representative-input\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib14","unstructured":"US Food and Drug Administration. Patient-focused drug development: methods to identify what is important to patients: guidance for industry, food and drug administration staff, and other stakeholders. 2022. \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-methods-identify-what-important-patients\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib15","unstructured":"US Food and Drug Administration. Patient-focused drug development: selecting, developing, or modifying fit-for-purpose clinical outcome assessments: draft guidance for industry, food and drug administration staff, and other stakeholders. 2022. \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib16","unstructured":"US Food and Drug Administration. Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making. 2023. \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints-regulatory\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib17","series-title":"The Palgrave Handbook of Critical Menstruation Studies","first-page":"181","article-title":"The menstrual mark: menstruation as social stigma","author":"Johnston-Robledo","year":"2020"},{"key":"10.1016\/j.contraception.2025.110829_bib18","first-page":"227","article-title":"Socio-cultural aspects of menstruation: an anthropological purview","volume":"61","author":"Das","year":"2008","journal-title":"East Anthropol"},{"key":"10.1016\/j.contraception.2025.110829_bib19","unstructured":"Fitch K, Bernstein SJ, Aguilar MD, Burnand B, LaCalle JR, Lazaro P, et al. The RAND\/UCLA appropriateness method user\u2019s manual. Santa Monica, CA: 2001. \u3008https:\/\/apps.dtic.mil\/sti\/citations\/ADA393235\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib20","doi-asserted-by":"crossref","first-page":"63","DOI":"10.2147\/JHL.S352500","article-title":"An adaptation of the RAND\/UCLA modified Delphi Panel Method in the time of COVID-19","volume":"14","author":"Broder","year":"2022","journal-title":"J Healthc Leadersh"},{"key":"10.1016\/j.contraception.2025.110829_bib21","doi-asserted-by":"crossref","first-page":"79","DOI":"10.7748\/nr.3.4.79.s8","article-title":"A critical review of the Delphi technique","volume":"3","author":"Beretta","year":"1996","journal-title":"Nurse Res"},{"key":"10.1016\/j.contraception.2025.110829_bib22","doi-asserted-by":"crossref","first-page":"1873","DOI":"10.1080\/03007995.2020.1816946","article-title":"Delphi, non-RAND modified Delphi, RAND\/UCLA appropriateness method and a novel group awareness and consensus methodology for consensus measurement: a systematic literature review","volume":"36","author":"Jandhyala","year":"2020","journal-title":"Curr Med Res Opin"},{"key":"10.1016\/j.contraception.2025.110829_bib23","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1111\/j.1365-2044.1980.tb03924.x","article-title":"Nominal group technique.\u00a0A\u00a0method\u00a0of\u00a0decision-making\u00a0by\u00a0committee","volume":"35","author":"Horton","year":"1980","journal-title":"Anaesthesia"},{"key":"10.1016\/j.contraception.2025.110829_bib24","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1080\/03007995.2020.1734920","article-title":"A novel method for observing proportional group awareness and consensus of items arising from list-generating questioning","volume":"36","author":"Jandhyala","year":"2020","journal-title":"Curr Med Res Opin"},{"key":"10.1016\/j.contraception.2025.110829_bib25","article-title":"The Global Interdisciplinary Group Technique: a virtual consensus-building methodology for developing recommendations among international interdisciplinary expert groups","author":"Chung","year":"2025","journal-title":"PLOS Glob Public Health"},{"key":"10.1016\/j.contraception.2025.110829_bib26","unstructured":"USG General Services Administration. Federal plain language guidelines 2023. \u3008https:\/\/www.plainlanguage.gov\/guidelines\/\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib27","unstructured":"World Wide Web Consortium (W3C). Web content accessibility guidelines 2023. \u3008https:\/\/www.w3.org\/standards\/\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib28","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1111\/j.1524-4733.2005.04054.x","article-title":"Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation","volume":"8","author":"Wild","year":"2005","journal-title":"Value Health"},{"key":"10.1016\/j.contraception.2025.110829_bib29","doi-asserted-by":"crossref","first-page":"430","DOI":"10.1111\/j.1524-4733.2008.00471.x","volume":"12","author":"Wild","year":"2009","journal-title":"Value Health"},{"key":"10.1016\/j.contraception.2025.110829_bib30","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1016\/j.jval.2014.06.005","article-title":"PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO mixed modes good research practices task force","volume":"17","author":"Eremenco","year":"2014","journal-title":"Value Health"},{"key":"10.1016\/j.contraception.2025.110829_bib31","doi-asserted-by":"crossref","first-page":"426","DOI":"10.1177\/2168479018793369","article-title":"Measurement equivalence of patient-reported outcome measures migrated to electronic formats: a review of evidence and recommendations for clinical trials and bring your own device","volume":"53","author":"Byrom","year":"2019","journal-title":"Ther Innov Regul Sci"},{"key":"10.1016\/j.contraception.2025.110829_bib32","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002689","article-title":"Machine learning in medicine: addressing ethical challenges","volume":"15","author":"Vayena","year":"2018","journal-title":"PLoS Med"},{"key":"10.1016\/j.contraception.2025.110829_bib33","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1146\/annurev-publhealth-040617-014208","article-title":"Big data in public health: terminology, machine learning, and privacy","volume":"39","author":"Mooney","year":"2018","journal-title":"Annu Rev Public Health"},{"key":"10.1016\/j.contraception.2025.110829_bib34","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1038\/s41591-018-0272-7","article-title":"Privacy in the age of medical big data","volume":"25","author":"Price","year":"2019","journal-title":"Nat Med"},{"key":"10.1016\/j.contraception.2025.110829_bib35","article-title":"Unraveling the ethical enigma: artificial intelligence in healthcare","volume":"15","author":"Jeyaraman","year":"2023","journal-title":"Cureus"},{"key":"10.1016\/j.contraception.2025.110829_bib36","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1038\/s41746-023-00913-9","article-title":"Considerations for addressing bias in artificial intelligence for health equity","volume":"6","author":"Abr\u00e0moff","year":"2023","journal-title":"NPJ Digit Med"},{"key":"10.1016\/j.contraception.2025.110829_bib37","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1002\/ijgo.12666","article-title":"The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions","volume":"143","author":"Munro","year":"2018","journal-title":"Int J Gynaecol Obstet"},{"key":"10.1016\/j.contraception.2025.110829_bib38","series-title":"Measurement in medicine","author":"de Vet","year":"2011"},{"key":"10.1016\/j.contraception.2025.110829_bib39","first-page":"45","article-title":"Critical issues in contraceptive and STI acceptability research","volume":"61","author":"Severy","year":"2005","journal-title":"J\u00a0Soc\u00a0Issues"},{"key":"10.1016\/j.contraception.2025.110829_bib40","doi-asserted-by":"crossref","first-page":"1889","DOI":"10.1007\/s11136-012-0344-y","article-title":"ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research","volume":"22","author":"Reeve","year":"2013","journal-title":"Qual Life Res"},{"key":"10.1016\/j.contraception.2025.110829_bib41","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1057\/s41285-017-0055-0","article-title":"In BMI we trust: reframing the body mass index as a measure of health","volume":"16","author":"Gutin","year":"2018","journal-title":"Soc Theory Health"},{"key":"10.1016\/j.contraception.2025.110829_bib42","doi-asserted-by":"crossref","first-page":"2254","DOI":"10.3390\/nu15102254","article-title":"Beyond BMI","volume":"15","author":"Bray","year":"2023","journal-title":"Nutrients"},{"key":"10.1016\/j.contraception.2025.110829_bib43","doi-asserted-by":"crossref","first-page":"1437","DOI":"10.1111\/1467-9566.13309","article-title":"Body mass index is just a number: conflating riskiness and unhealthiness in discourse on body size","volume":"43","author":"Gutin","year":"2021","journal-title":"Soc\u00a0Health Illn"},{"key":"10.1016\/j.contraception.2025.110829_bib44","doi-asserted-by":"crossref","first-page":"s246","DOI":"10.1007\/s00592-003-0077-z","article-title":"Validity of body composition methods across ethnic population groups","volume":"40","author":"Deurenberg","year":"2003","journal-title":"Acta Diabetol"},{"key":"10.1016\/j.contraception.2025.110829_bib45","unstructured":"US Food and Drug Administration. Establishing effectiveness and safety for hormonal drug products intended to prevent pregnancy guidance for industry 2019. \u3008https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/establishing-effectiveness-and-safety-hormonal-drug-products-intended-prevent-pregnancy-guidance\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib46","unstructured":"Lin G and\u00a0Rodriguez R. Weighted methods for analyzing missing data with the GEE procedure. SAS Conference Proceedings: SAS Global Forum 2014, 2014. https:\/\/support.sas.com\/resources\/papers\/proceedings14\/SAS166-2014.pdf (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib47","series-title":"PROC GEE. SAS\/STAT\u00ae 15.2 user\u2019s guide","author":"SAS Institute Inc","year":"2020"},{"key":"10.1016\/j.contraception.2025.110829_bib48","first-page":"691","article-title":"Regression models for longitudinal binary responses with informative drop\u2010outs","volume":"57","author":"Fitzmaurice","year":"1995","journal-title":"J\u00a0R\u00a0Stat\u00a0Soc: Series B (Methodol)"},{"key":"10.1016\/j.contraception.2025.110829_bib49","first-page":"1184","article-title":"Re-identification attacks\u2014a systematic literature review","volume":"36","author":"Henriksen-Bulmer","year":"2016","journal-title":"Int J Inf Manage"},{"key":"10.1016\/j.contraception.2025.110829_bib50","doi-asserted-by":"crossref","first-page":"e239","DOI":"10.1016\/S2589-7500(22)00234-5","article-title":"Does deidentification of data from wearable devices give us a false sense of security? A systematic review","volume":"5","author":"Chikwetu","year":"2023","journal-title":"Lancet Digit Health"},{"key":"10.1016\/j.contraception.2025.110829_bib51","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1126\/science.1229566","article-title":"Identifying personal genomes by surname inference","volume":"339","author":"Gymrek","year":"2013","journal-title":"Science"},{"key":"10.1016\/j.contraception.2025.110829_bib52","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1038\/nrd.2016.264","article-title":"Regulatory watch: the target product profile as a tool for regulatory communication: advantageous but underused","volume":"16","author":"Tyndall","year":"2017","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/j.contraception.2025.110829_bib53","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0306491","article-title":"Measurement of changes to the menstrual cycle: a transdisciplinary systematic review evaluating measure quality and utility for clinical trials","volume":"19","author":"Mackenzie","year":"2024","journal-title":"PLoS One"},{"key":"10.1016\/j.contraception.2025.110829_bib54","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1017\/S0021932000000511","article-title":"The statistical analysis of menstrual bleeding patterns","volume":"9","author":"Snowden","year":"1977","journal-title":"J Biosoc Sci"},{"key":"10.1016\/j.contraception.2025.110829_bib55","doi-asserted-by":"crossref","first-page":"42","DOI":"10.2307\/1964872","article-title":"An approach to the analysis of menstrual patterns in the critical evaluation of contraceptives","volume":"7","author":"Rodriguez","year":"1976","journal-title":"Stud Fam Plann"},{"key":"10.1016\/j.contraception.2025.110829_bib56","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/0010-7824(86)90006-5","article-title":"The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction","volume":"34","author":"Belsey","year":"1986","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib57","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1016\/0010-7824(88)90035-2","article-title":"The analysis of menstrual bleeding patterns: a review","volume":"38","author":"Belsey","year":"1988","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib58","first-page":"27","article-title":"Vaginal bleeding patterns \u2014 the problem and an example data set","volume":"3","author":"Machin","year":"1987","journal-title":"Appl\u00a0Stoch\u00a0Model\u00a0Data Anal"},{"key":"10.1016\/j.contraception.2025.110829_bib59","first-page":"125","article-title":"The analysis of menstrual bleeding patterns: a review","volume":"3","author":"Belsey","year":"1987","journal-title":"Appl\u00a0Stoch\u00a0Model\u00a0Data Anal"},{"key":"10.1016\/j.contraception.2025.110829_bib60","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1002\/sim.4780100210","article-title":"The description of menstrual bleeding patterns: towards fewer measures","volume":"10","author":"Belsey","year":"1991","journal-title":"Stat Med"},{"key":"10.1016\/j.contraception.2025.110829_bib61","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1016\/j.contraception.2006.08.008","article-title":"Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception","volume":"75","author":"Mishell","year":"2007","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib62","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1016\/j.contraception.2006.08.012","article-title":"Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials","volume":"75","author":"Mishell","year":"2007","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2025.110829_bib63","unstructured":"US Food and Drug Administration. Advisory Committee for Reproductive Health Drugs final summary meeting minutes 2007. \u3008https:\/\/wayback.archive-it.org\/7993\/20170404050830\/https:\/\/www.fda.gov\/ohrms\/dockets\/ac\/07\/minutes\/2007\u20134274m1.pdf\u3009 (accessed July 31, 2024)."},{"key":"10.1016\/j.contraception.2025.110829_bib64","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1097\/AOG.0000000000003816","article-title":"The imperative for transgender and gender nonbinary inclusion","volume":"135","author":"Moseson","year":"2020","journal-title":"Obstet Gynecol"},{"key":"10.1016\/j.contraception.2025.110829_bib65","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1080\/13625187.2021.2000960","article-title":"Contraceptive technology research and development: a call for inclusion of trans and gender diverse individuals assigned female at birth","volume":"27","author":"Sims","year":"2022","journal-title":"Eur J Contracept Reprod Health Care"},{"key":"10.1016\/j.contraception.2025.110829_bib66","doi-asserted-by":"crossref","DOI":"10.1126\/sciadv.abm7201","article-title":"Investigating trends in those who experience menstrual bleeding changes after SARS-CoV-2 vaccination","volume":"8","author":"Lee","year":"2022","journal-title":"Sci Adv"},{"key":"10.1016\/j.contraception.2025.110829_bib67","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1097\/AOG.0000000000004695","article-title":"Association between menstrual cycle length and Coronavirus disease 2019 (COVID-19) vaccination: a U.S. cohort","volume":"139","author":"Edelman","year":"2022","journal-title":"Obstet Gynecol"},{"key":"10.1016\/j.contraception.2025.110829_bib68","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1038\/s41746-022-00711-9","article-title":"COVID-19 vaccination and menstrual cycle length in the Apple Women\u2019s Health Study","volume":"5","author":"Gibson","year":"2022","journal-title":"NPJ Digit Med"},{"key":"10.1016\/j.contraception.2025.110829_bib69","doi-asserted-by":"crossref","first-page":"4327","DOI":"10.1016\/j.vaccine.2023.06.012","article-title":"COVID-19 vaccination and menstrual cycle characteristics: a prospective cohort study","volume":"41","author":"Wesselink","year":"2023","journal-title":"Vaccine"},{"key":"10.1016\/j.contraception.2025.110829_bib70","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0277288","article-title":"The effect of COVID-19 vaccination on the menstrual pattern and mental health of the medical students: a mixed-methods study from a low and middle-income country","volume":"17","author":"Kareem","year":"2022","journal-title":"PLoS One"}],"container-title":["Contraception"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0010782425000204?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0010782425000204?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T13:16:23Z","timestamp":1777641383000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0010782425000204"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":70,"alternative-id":["S0010782425000204"],"URL":"https:\/\/doi.org\/10.1016\/j.contraception.2025.110829","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2024.04.04.24305350","asserted-by":"object"}]},"ISSN":["0010-7824"],"issn-type":[{"value":"0010-7824","type":"print"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials","name":"articletitle","label":"Article Title"},{"value":"Contraception","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.contraception.2025.110829","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"110829"}}