Objective: We sought to develop consensus recommendations for improved measurement of contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials to build upon previous standardization efforts. Study Design: We undertook a virtual consensus-building process using a modified Delphi approach, incorporating aspects of Nominal Group Technique and the Jandhyala method. The process consisted of four half-day meetings, developing recommendations within five topical working groups, a series of consensus questionnaires to assess recommendation agreement on a 4-point Likert-like scale, and opportunities for input and feedback throughout the process. Recommendations required at least 75% consensus to be included. Results: Our interdisciplinary group--from 26 organizations and 13 countries in five global regions across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies--developed 44 consensus recommendations. These included recommendations on standardization, patient-reported outcome measure development aligned with current regulatory guidance, trial design, protocol development, participant recruitment, data collection, data analysis, and areas for exploratory research. Seven recommendations were deemed a priority by over 85% of our group. Conclusion: Using a formal consensus-building process, we reached high levels of agreement around recommendations for more standardized and patient-centered measurement of CIMCs in contraceptive clinical trials, now and in the future.

AEB has received research funding mediated through JHU from: Merck, Chemo Pharmaceuticals, Dare Bioscience, and NICHD. KBHC received a small honorarium from Pfizer to participate in their Tales From the Uterus podcast series in the summer/fall of 2023. EC is an Exeltis employee. MDC has received speaking honoraria from Gedeon Richter, Mayne, OLIC, and Organon, served on Advisory Boards for Gedeon Richter and Mayne, has stock options with Femasys, and has consulted for Estetra SRL, Medicines360, and Organon. The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for Dr. Creinin from Chemo Research SL, Evofem, Femasys, Medicines360, Merck, Sebela, and Sumitomo Pharma. HODC has received clinical research support for laboratory consumables and staff from Bayer AG (Paid to Institution) and has provided consultancy advice (Paid to Institution) for Bayer AG, PregLem SA, Gedeon Richter, Vifor Pharma UK Ltd, AbbVie Inc., Myovant Sciences GmbH, and Theramex. HODC has received royalties from UpToDate for an article on abnormal uterine bleeding. AE has received travel reimbursement from ACOG, WHO, CDC, and honoraria from Gynuity for committee activities. AE receives royalties from Up to Date, Inc. Oregon Health & Science University receives research funding from OHSU Foundation, Gates, Merck, HRA Pharma, and NIH where AE is the principal investigator. CG is an employee of Bayer AG. All other authors have no conflicts of interest to declare.

This expert consultation was made possible by the generous support of the American people through the U.S. Agency for International Development (USAID), provided to FHI 360 through cooperative agreement 7200AA20CA00016. The contents are the responsibility of FHI 360, the views expressed are those of the authors, and contents and views do not necessarily reflect those of any funder, including USAID, the National Institutes of Health, the United States Government, or the Reckitt Global Hygiene Institute Fellowship. ACLM, SC, EH, NM, AEB, RLC, AFC, ECC, LJD, AM, KN, MS, DT, and EET were supported but USAID cooperative agreement 7200AA20CA00016, with SC also supported by the Bill & Melinda Gates Foundation (OPP1200867) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32 HD52468) and MS also supported by the Bill & Melinda Gates Foundation (INV-045483). EC was supported by Exeltis, and CEN by USAID. LB, VB, KBHC, MDC, HODC, GFD, AE, LBH, JH, CRTJ, SPSK, DM, KAM, JAM, FMO, CBP, CSV, RSW, JAS, LMS, and OV received an honorarium supported by USAID cooperative agreement 7200AA20CA00016 that was declined by other authors. In addition, GFD was also supported by USAID Cooperative Agreement 7200AA20CA00019 provided to CONRAD/Eastern Virginia Medical School, JH was also supported by a Reckitt Global Hygiene Institute Fellowship, JAM was also supported by Wellcome Fellowship 209589/Z/17/Z, FMO was also supported by EVIHDAF, and RSW was also supported by The Population Council.

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