Part 1: Formative study for developing patient-reported outcomes (PROs) for measuring contraceptive-induced menstrual changes (CIMCs)

This formative qualitive study was designed to produce data to develop and refine a patient-reported outcome mesure (PROM) to measure contraceptive-induced menstrual changes (CIMCs) for future contraceptive clinical trials. Focus group discussions were conducted with women of reproductive age (18-49-yrs-old) who report experiencing contraceptive-induced menstrual changes (CIMCs) in three sites – 1) Portland, Oregon, United States, 2) Santo Domingo, Dominican Republic, and 3) Durban, South Africa. 18 Focus group discussions were conducted with 102 women (4-7 per group) from 11/21/24 to 2/28/2025 in South Africa ; 1/24/25 to 2/6/25 in Dominican Republic; 8/26/25 to 9/18/25 in United States. This work was supported, in whole by the Gates Foundation [INV-062479]. The conclusions and opinions expressed in this work are those of the author(s) alone and shall not be attributed to the Foundation.