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Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

This study is looking at how well two common hormonal treatments, the levonorgestrel intrauterine system (LNG-IUD) and norethindrone acetate (NETA), work for young women and adolescents (ages 10-24) who have heavy menstrual bleeding and a bleeding disorder like Von Willebrand Disease. Researchers want to see if these treatments improve bleeding, quality of life, and iron levels after six months. The study will compare the two treatments and also compare LNG-IUD results to a group without a bleeding disorder. The goal is to understand the benefits of these treatments for this specific group. The study is currently recruiting up to 300 participants, but its overall status is unclear.

Study design
This is an observational study involving up to 300 participants. It will compare outcomes between two different treatments.
What's involved
Participants will be followed for 6 months to assess treatment outcomes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05916469

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Recruiting
Not specifiedAges 10–24Observational
Oregon Health and Science University
~300 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Levonorgestrel Intrauterine SystemNorethindrone Acetate

At a glance

Recruiting sites
1 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment success rate
Measured over 6 months

Conditions

Heavy Menstrual Bleeding
Bleeding Disorder
Von Willebrand Diseases

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Menorrhagiavon Willebrand Disease

NCT05916469

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Oregon Health & Science University

    Portland, Oregonstudy coordinator listed

    Recruiting

  • University of Washington

    Seattle, Washingtonstudy coordinator listed

    Not yet recruiting

  • Children's Mercy

    Kansas City, Missourino site contact published

    Not yet recruiting

  • Colorado Anschutz Medical Campus

    Aurora, Coloradono site contact published

    Not yet recruiting

  • Emory

    Atlanta, Georgiano site contact published

    Not yet recruiting

  • Penn State Health

    Hershey, Pennsylvaniano site contact published

    Not yet recruiting

  • Seattle Children's Hospital

    Seattle, Washingtonno site contact published

    Not yet recruiting

  • Stanford

    Palo Alto, Californiano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Maureen Baldwin, MD MPH · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
  • Allison Wheeler · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

OHSU Women's Health Research Unit
[email protected]
5034943666
Email the study team

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Eligibility criteria

Inclusion

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

Pregnant or seeking pregnancy

What this trial measures

  • Treatment success rate6 months

    Proportion with pictorial blood loss assessment score \<50 points