Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Recruiting now

Conditions studied: Heavy Menstrual Bleeding, Bleeding Disorder, Von Willebrand Diseases

In brief

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 facts

Study ID

NCT05916469

Run by

Oregon Health and Science University

People needed

300

Starts

2025-09-24

Expected to finish

2029-06-01

Last updated by the study team

2025-12-17

Who can join

Age: 10 and older, up to 24. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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+)
• Must meet trial criteria for heavy menstrual bleeding
• Must meet trial criteria for a bleeding disorder or have minimum workup to rule out bleeding disorder

You may not qualify if…

• Pregnant or seeking pregnancy

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States
• 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
• University of Washington — Seattle, Washington, United States
• Penn State Health — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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