Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

ABSTRACT Heavy menstrual bleeding (HMB) is common among adolescents and young adults with a heritable bleeding disorder (BD) and negatively impacts health-related quality of life and physical and mental health status. Effective treatment options are available that decrease bleeding and improve quality of life, but were not

studied in those with BD, so we do not know if there is similar effectiveness in this condition. We also do not know the impact of treatment on diagnostic testing for BD or on improvement of iron deficiency. Given these gaps in knowledge, the primary objective of the Heavy Menstrual Bleeding Progestin Treatment in

Bleeding Disorders Study is to conduct a multicenter prospective pragmatic trial, enrolling adolescents and young adults with HMB cared for at collaborating multi-disciplinary menstrual clinic sites nationally who are choosing to initiate hormonal menstrual suppression with a progestin treatment option (N=300). In Aim 1, we

will compare outcomes related to (a) bleeding management, (b) quality of life, and (c) repletion of iron storage levels after six months of treatment with either 52 mg levonorgestrel-releasing intrauterine system (LNG-IUD) or oral norethindrone acetate 5 mg daily (NETA) in those with a diagnosed heritable BD. The primary outcome

will be treatment success with a Pictorial Blood Loss Assessment Chart (PBAC) score