Considerations For Clinical Studies In Heavy Menstrual Bleeding

Heavy menstrual bleeding (HMB) is a common form of Abnormal Uterine Bleeding (AUB). which is denoted by bleeding of abnormal quantity, duration or schedule. HMB refers to bleeding that is regular, associated with ovulatory cycles and involves monthly blood loss greater than 80 ml, double the normal quantity. HMB compromises quality of life for many women and can result in anemia. Approximately 15% of women with HMB have von Willebrand Disease, a genetic bleeding disorder.

Accurate measures of menstrual blood loss are essential for evaluating the efficacy of drugs and medical devices for HMB. The gold standard measure is the alkaline hematin method, a chemical measurement of blood in used sanitary products. This method is required in studies of drugs for HMB.

Continue reading to learn more about the unique operational and methodological considerations of HMB studies.