About this trial
The goal of this multicenter prospective observational study and registry of U.S. adolescents and young adults with heritable bleeding disorders is to determine the bleeding outcomes, satisfaction, hemostatic parameter changes, and patient reported quality of life after 6 months of use of either of two commonly used hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application the study will compare the two treatments and compare outcomes after LNG-IUD treatment results to a control group without a bleeding disorder, with the goal of determining the benefits and expected outcomes of these treatment options for this population.
Eligibility criteria
Qualifiers
Post-menarcheal
Ages 10-24
Decision to initiate a trial of progestin therapy with either LNG-IUD or NETA
Able to provide assent and written informed consent by one parent (ages <18) or written informed consent (age 18+)
Disqualifiers
Pregnant or seeking pregnancy
Trial design
Treatments tested in this trial
- Levonorgestrel Intrauterine System
- Norethindrone Acetate
Treatment groups
Sponsors and collaborators
Oregon Health and Science University
Lead sponsor
University of Washington
Collaborator
NIH National Heart, Lung, and Blood Institute
Collaborator