Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials
Consensus recommendations on measuring bleeding changes and related outcomes in contraceptive clinical trials can improve reporting of standardized, patient-centered outcomes in future product labeling. These improvements can enable healthcare providers to offer more relevant guidance on contraceptives and users to make more informed decisions about their choice of method.
Authors
- Thomas Faustmann
- Alexandria K. Mickler (ORCID: https://orcid.org/0000-0003-4800-3465)
- Alice F. Cartwright (ORCID: https://orcid.org/0000-0002-1557-8062)
- Amelia C. L. Mackenzie (ORCID: https://orcid.org/0000-0003-1721-805X)
- Rebecca L. Callahan (ORCID: https://orcid.org/0000-0001-5808-0320)
- Julie Hennegan (ORCID: https://orcid.org/0000-0003-2011-1595)
- Mitchell D. Creinin (ORCID: https://orcid.org/0000-0001-5967-8180)
- Marsden Solomon
- Jennifer Smit (ORCID: https://orcid.org/0000-0003-4992-0900)
- Olivia Vandeputte
- Lisa Soule
- Sharon L. Achilles (ORCID: https://orcid.org/0000-0002-7478-8262)
- Simon P. S. Kibira (ORCID: https://orcid.org/0000-0002-7385-423X)
- Jacqueline A. Maybin (ORCID: https://orcid.org/0000-0003-1560-2840)
- Anne E. Burke (ORCID: https://orcid.org/0009-0009-4849-1068)
- Hilary Critchley (ORCID: https://orcid.org/0000-0003-1913-4044)
- Kavita Nanda (ORCID: https://orcid.org/0000-0001-7650-2929)
- Nora Miller
- Kathryn B. H. Clancy (ORCID: https://orcid.org/0000-0002-6901-254X)
- Diana Blithe (ORCID: https://orcid.org/0000-0001-5224-9340)
- Diana Mansour (ORCID: https://orcid.org/0000-0003-1283-1365)
- Christoph Gerlinger (ORCID: https://orcid.org/0000-0003-4538-6413)
- Elizabeth E. Tolley (ORCID: https://orcid.org/0000-0002-9823-3675)
- Kristen A. Matteson (ORCID: https://orcid.org/0000-0003-4405-3449)
- Douglas Taylor (ORCID: https://orcid.org/0000-0003-4658-5369)
- Enrico Colli (ORCID: https://orcid.org/0009-0008-9137-0950)
- Vivian Brache (ORCID: https://orcid.org/0000-0003-2621-4739)
- Carolina Sales Vieira (ORCID: https://orcid.org/0000-0003-2933-5755)
- Kevin J. Peine (ORCID: https://orcid.org/0000-0002-6153-3615)
- A. Cordova (ORCID: https://orcid.org/0000-0001-7843-1431)
- C. Leigh Allen (ORCID: https://orcid.org/0000-0001-5744-9659)
- Luís Bahamondes (ORCID: https://orcid.org/0000-0002-7356-8428)
- Chukwuemeka E Nwachukwu (ORCID: https://orcid.org/0000-0003-3660-5899)
- Funmilola M. OlaOlorun (ORCID: https://orcid.org/0000-0001-5544-2875)
- Alison Edelman (ORCID: https://orcid.org/0000-0001-5040-7288)
- Chelsea B. Polis (ORCID: https://orcid.org/0000-0002-1031-7074)
- Emily Hoppes (ORCID: https://orcid.org/0000-0002-0178-4068)
- Lisa B. Haddad (ORCID: https://orcid.org/0000-0002-7631-6760)
- Laneta J. Dorflinger
- Andrés Martínez (ORCID: https://orcid.org/0000-0002-0763-1978)
- Stephanie Chung (ORCID: https://orcid.org/0000-0002-2383-0512)
- Cássia Raquel Teatin Juliato
- Elizabeth C. Costenbader
- Regine Sitruk-Ware
- Gustavo F. Doncel (ORCID: https://orcid.org/0009-0009-9641-1325)
Institutions
- Family Health International 360 (US)
- National Institutes of Health (US)
- Gates Foundation (US)
- Johns Hopkins University (US)
- Burnet Institute (AU)
- Eastern Virginia Medical School (US)
- University of Illinois Urbana-Champaign (US)
- Oregon Health & Science University (US)
- University of Massachusetts Chan Medical School (US)
- Universidade de São Paulo (BR)
- Universidade Estadual de Campinas (UNICAMP) (BR)
- University of Ibadan (NG)
- University of the Witwatersrand (ZA)
- United States Agency for International Development (US)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Cambridge Information Group (US)
- Waterbury Hospital (US)
- MRC Centre for Regenerative Medicine (GB)
- MRC Centre for Reproductive Health (GB)
- Unidades Centrales Científico-Técnicas (ES)
- Newcastle upon Tyne Hospital (GB)
- Profamilia (DO)
- Population Council (US)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (US)
- Department of Health (ZA)
- Institute for Reproductive Health (US)
- Bayer (Germany) (DE)
- Makerere University (UG)
- University of California, Davis (US)
- Saarland University (DE)
- University of Edinburgh (GB)
Publication Details
- Journal
- Contraception
- Published
- 2025-01-27
- DOI
- https://doi.org/10.1016/j.contraception.2025.110829
- Citations
- 1
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 1.88