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

300 Participants
are divided into 3 treatment groups

Locations

9
California
Stanford94304, Palo Alto United States
Colorado
Colorado Anschutz Medical Campus80045, Aurora United States
Georgia
Emory30322, Atlanta United States
Michigan
University of Michigan Medicine48109, Ann Arbor United States

Sponsors and collaborators

Oregon Health and Science University

Lead sponsor

University of Washington

Collaborator

NIH National Heart, Lung, and Blood Institute

Collaborator