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Hormonal showdown: which treatment tames heavy periods in bleeding disorders?

NCT ID NCT05916469

Disease control Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 300 teens and young adults (ages 10-24) with inherited bleeding disorders who choose either a levonorgestrel IUD or norethindrone acetate pills for heavy menstrual bleeding. Researchers will track bleeding patterns, satisfaction, and quality of life over six months to see which option works better. The goal is to provide clear guidance on managing heavy periods in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levonorgestrel intrauterine system (LNG-IUD) and norethindrone acetate (NETA)
What this could lead to
If this study succeeds, it could help doctors choose the best hormonal treatment for heavy menstrual bleeding in young people with bleeding disorders, improving their quality of life.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The study is also relatively small and focused on a specific age group, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adolescents and young adults ages 10-24 with and without a heritable bleeding disorder who receive medical care for heavy menstrual bleeding at a participating U.S. clinical site. All clinical sites participate in a national consortium of interdisciplinary hematology-gynecology clinics.

Ages

10 to 24 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * Pregnant or seeking pregnancy

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

hemorrhagic disease hereditary von Willebrand disease Menorrhagia vascular hemostatic disease von Willebrand disease (hereditary or acquired)

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleeding disorder Heavy menstrual bleeding Von Willebrand diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Mercy

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64108, United States

  • Colorado Anschutz Medical Campus

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Emory

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn State Health

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17003, United States

  • Seattle Children's Hospital

    NOT_YET_RECRUITING

    Seattle, Washington, 98105, United States

  • Stanford

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • University of Michigan Medicine

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Washington

    NOT_YET_RECRUITING

    Seattle, Washington, 98101, United States

    Contact Email: •••••@•••••

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