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Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Sponsor: Oregon Health and Science University
Summary
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.
Key Details
Gender
FEMALE
Age Range
10 Years - 24 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-09-24
Completion Date
2029-06
Last Updated
2025-12-17
Healthy Volunteers
No
Interventions
Levonorgestrel Intrauterine System
52 mg levonorgestrel intrauterine system
Norethindrone Acetate
norethindrone acetate 5 mg daily
Locations (9)
Stanford
Palo Alto, California, United States
Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Emory
Atlanta, Georgia, United States
University of Michigan Medicine
Ann Arbor, Michigan, United States
Children's Mercy
Kansas City, Missouri, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Health
Hershey, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States