Study of Progestin Treatments for Heavy Menstrual Bleeding in Young Women with Bleeding Disorders

What this Trial Is About

This research aims to better understand heavy menstrual bleeding HMB in adolescents and young adults who have inherited bleeding disorders. It focuses on how two commonly used hormonal treatments for menstrual suppressionlevonorgestrel-releasing intrauterine device LNG-IUD and oral norethindrone acetate NETAaffect bleeding outcomes, patient satisfaction, changes in blood clotting parameters, and quality of life over six months. The study also compares results from those using LNG-IUD with individuals without bleeding disorders to better understand treatment benefits and expected outcomes in this population. Participants will choose to start either the LNG-IUD, a device that releases levonorgestrel hormone, or daily oral norethindrone acetate at 5 mg. The study includes three groups those with bleeding disorders using LNG-IUD, those without bleeding disorders using LNG-IUD, and those with bleeding disorders using NETA. The study observes the treatments prospectively without assigning them randomly, focusing on real-world use. Researchers will track treatment success, bleeding management, quality of life, iron levels, and blood clotting changes over six months. During the study, participants will complete assessments including bleeding diaries using the Pictorial Blood Loss Assessment Chart, quality of life questionnaires specific to adolescents and young adults, and blood tests to measure iron and clotting factors before and after treatment. The study will also monitor device continuation and expulsion rates for LNG-IUD users. The total participation period involves six months of observation and data collection to evaluate treatment outcomes and effects on diagnostic testing for bleeding disorders.

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study