RecruitingNCT05916469

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study


Sponsor

Oregon Health and Science University

Enrollment

300 participants

Start Date

Sep 24, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 24 Years

Inclusion Criteria6

  • 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

Exclusion Criteria1

  • Pregnant or seeking pregnancy

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Interventions

DRUGLevonorgestrel Intrauterine System

52 mg levonorgestrel intrauterine system

DRUGNorethindrone 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

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NCT05916469


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