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Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.

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Title: Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.
Authors: Mackenzie ACL; Global Health and Population, FHI 360, Washington, DC, United States. Electronic address: amackenzie@fhi360.org., Chung S; Global Health and Population, FHI 360, Durham, NC, United States; Department of Maternal and Child Health, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, United States., Hoppes E; Global Health and Population, FHI 360, Durham, NC, United States., Miller N; Mann Global Health, Waterbury, VT, United States., Burke AE; Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States., Achilles SL; Bill & Melinda Gates Foundation, Seattle, WA, United States., Allen CL; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, United States., Bahamondes L; Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, São Paulo, Brazil., Blithe DL; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, United States., Brache V; Profamilia, Santo Domingo, Dominican Republic., Callahan RL; Global Health and Population, FHI 360, Durham, NC, United States., Cartwright AF; Global Health and Population, FHI 360, Durham, NC, United States., Clancy KBH; University of Illinois Urbana-Champaign, Urbana, IL, United States., Colli E; Exeltis R&D, Madrid, Spain., Cordova-Gomez A; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States., Costenbader EC; Global Health and Population, FHI 360, Durham, NC, United States., Creinin MD; University of California, Davis, Sacramento, CA, United States., Critchley HOD; Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, Scotland, UK., Doncel GF; CONRAD - Eastern Virginia Medical School, Norfolk, VA, United States., Dorflinger LJ; Global Health and Population, FHI 360, Durham, NC, United States., Edelman A; Oregon Health and Science University, Portland, OR, United States., Faustmann T; Bayer AG, Berlin, Germany., Gerlinger C; Bayer AG, Berlin, Germany; Universität des Saarlandes, Homburg, Saarland, Germany., Haddad LB; Center for Biomedical Research, Population Council, New York, NY, United States., Hennegan J; Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia., Juliato CRT; Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, São Paulo, Brazil., Kibira SPS; Makerere University School of Public Health, Kampala, Uganda., Mansour D; Women's Health Directorate, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, England, UK., Martinez A; Global Health and Population, FHI 360, Atlanta, GA, United States., Matteson KA; University of Massachusetts Chan Medical School, Worcester, MA, United States., Maybin JA; Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, Scotland, UK., Mickler AK; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States., Nanda K; Global Health and Population, FHI 360, Durham, NC, United States., Nwachukwu CE; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States., OlaOlorun FM; College of Medicine, University of Ibadan, Ibadan, Oyo, Nigeria., Peine KJ; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States., Polis CB; Center for Biomedical Research, Population Council, New York, NY, United States., Vieira CS; Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil., Sitruk-Ware R; Center for Biomedical Research, Population Council, New York, NY, United States., Smit JA; Wits MatCH Research Unit, Department of Obstetrics and Gyanaecology, The University of the Witwatersrand, Durban, KwaZulu-Natal, South Africa., Solomon M; FHI 360, Nairobi, Kenya., Soule LM; Independent Consultant, Bethesda, MD, United States., Taylor D; Global Health and Population, FHI 360, Durham, NC, United States., Tolley EE; Global Health and Population, FHI 360, Durham, NC, United States., Vandeputte O; MSI Reproductive Choices, London, England, UK.
Source: Contraception [Contraception] 2025 Jun; Vol. 146, pp. 110829. Date of Electronic Publication: 2025 Jan 27.
Publication Type: Journal Article; Consensus Statement
Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 0234361 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0518 (Electronic) Linking ISSN: 00107824 NLM ISO Abbreviation: Contraception Subsets: MEDLINE
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Electronic address: amackenzie@fhi360.org.<br /><searchLink fieldCode="AU" term="%22Chung+S%22">Chung S</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States; Department of Maternal and Child Health, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, United States.<br /><searchLink fieldCode="AU" term="%22Hoppes+E%22">Hoppes E</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Miller+N%22">Miller N</searchLink>; Mann Global Health, Waterbury, VT, United States.<br /><searchLink fieldCode="AU" term="%22Burke+AE%22">Burke AE</searchLink>; Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.<br /><searchLink fieldCode="AU" term="%22Achilles+SL%22">Achilles SL</searchLink>; Bill & Melinda Gates Foundation, Seattle, WA, United States.<br /><searchLink fieldCode="AU" term="%22Allen+CL%22">Allen CL</searchLink>; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, United States.<br /><searchLink fieldCode="AU" term="%22Bahamondes+L%22">Bahamondes L</searchLink>; Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Blithe+DL%22">Blithe DL</searchLink>; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, United States.<br /><searchLink fieldCode="AU" term="%22Brache+V%22">Brache V</searchLink>; Profamilia, Santo Domingo, Dominican Republic.<br /><searchLink fieldCode="AU" term="%22Callahan+RL%22">Callahan RL</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Cartwright+AF%22">Cartwright AF</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Clancy+KBH%22">Clancy KBH</searchLink>; 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CONRAD - Eastern Virginia Medical School, Norfolk, VA, United States.<br /><searchLink fieldCode="AU" term="%22Dorflinger+LJ%22">Dorflinger LJ</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Edelman+A%22">Edelman A</searchLink>; Oregon Health and Science University, Portland, OR, United States.<br /><searchLink fieldCode="AU" term="%22Faustmann+T%22">Faustmann T</searchLink>; Bayer AG, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Gerlinger+C%22">Gerlinger C</searchLink>; Bayer AG, Berlin, Germany; Universität des Saarlandes, Homburg, Saarland, Germany.<br /><searchLink fieldCode="AU" term="%22Haddad+LB%22">Haddad LB</searchLink>; Center for Biomedical Research, Population Council, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Hennegan+J%22">Hennegan J</searchLink>; Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia.<br /><searchLink fieldCode="AU" term="%22Juliato+CRT%22">Juliato CRT</searchLink>; Department of Obstetrics and Gynecology, University of Campinas, Faculty of Medical Sciences, Campinas, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Kibira+SPS%22">Kibira SPS</searchLink>; Makerere University School of Public Health, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Mansour+D%22">Mansour D</searchLink>; Women's Health Directorate, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, England, UK.<br /><searchLink fieldCode="AU" term="%22Martinez+A%22">Martinez A</searchLink>; Global Health and Population, FHI 360, Atlanta, GA, United States.<br /><searchLink fieldCode="AU" term="%22Matteson+KA%22">Matteson KA</searchLink>; University of Massachusetts Chan Medical School, Worcester, MA, United States.<br /><searchLink fieldCode="AU" term="%22Maybin+JA%22">Maybin JA</searchLink>; Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, Scotland, UK.<br /><searchLink fieldCode="AU" term="%22Mickler+AK%22">Mickler AK</searchLink>; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States.<br /><searchLink fieldCode="AU" term="%22Nanda+K%22">Nanda K</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Nwachukwu+CE%22">Nwachukwu CE</searchLink>; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States.<br /><searchLink fieldCode="AU" term="%22OlaOlorun+FM%22">OlaOlorun FM</searchLink>; College of Medicine, University of Ibadan, Ibadan, Oyo, Nigeria.<br /><searchLink fieldCode="AU" term="%22Peine+KJ%22">Peine KJ</searchLink>; Research, Technology, and Utilization Division, Office of Population and Reproductive Health, Bureau for Global Health, United States Agency for International Development and the Public Health Institute, Washington, DC, United States.<br /><searchLink fieldCode="AU" term="%22Polis+CB%22">Polis CB</searchLink>; Center for Biomedical Research, Population Council, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Vieira+CS%22">Vieira CS</searchLink>; Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Sitruk-Ware+R%22">Sitruk-Ware R</searchLink>; Center for Biomedical Research, Population Council, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Smit+JA%22">Smit JA</searchLink>; Wits MatCH Research Unit, Department of Obstetrics and Gyanaecology, The University of the Witwatersrand, Durban, KwaZulu-Natal, South Africa.<br /><searchLink fieldCode="AU" term="%22Solomon+M%22">Solomon M</searchLink>; FHI 360, Nairobi, Kenya.<br /><searchLink fieldCode="AU" term="%22Soule+LM%22">Soule LM</searchLink>; Independent Consultant, Bethesda, MD, United States.<br /><searchLink fieldCode="AU" term="%22Taylor+D%22">Taylor D</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Tolley+EE%22">Tolley EE</searchLink>; Global Health and Population, FHI 360, Durham, NC, United States.<br /><searchLink fieldCode="AU" term="%22Vandeputte+O%22">Vandeputte O</searchLink>; MSI Reproductive Choices, London, England, UK.
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