Home › Menorrhagia › NCT05916469

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Who can join

Ages 10 to 24 · Women

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

About the study

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.

What is being tested

• Levonorgestrel Intrauterine System (drug)
• Norethindrone Acetate (drug)

Sponsor: Oregon Health and Science University · Participants: 300 · Started: Sep 24, 2025

Contact the study team

• OHSU Women's Health Research Unit · Phone: 5034943666
• Maureen Baldwin, MD MPH · Phone: 5034949762

Official record on ClinicalTrials.gov — NCT05916469

Locations in the U.S.

Conditions

• Menorrhagia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.