Progestin options for heavy periods in young people with inherited bleeding disorders
Official title: Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Run by Oregon Health and Science University · NCT05916469 · Data updated 2026-11-12
This project will test two progestin menstrual treatments—a levonorgestrel IUD and daily norethindrone acetate—in adolescents and young adults (ages 10–24) with inherited bleeding disorders to see which better reduces heavy menstrual bleeding over six months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 24 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 8 sites (Palo Alto, California and 7 other locations) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT05916469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Post-menarcheal adolescents and young adults ages 10–24 who meet trial criteria for heavy menstrual bleeding and have or are undergoing workup for an inherited bleeding disorder and who have decided to start either an LNG-IUD or daily norethindrone acetate are ideal candidates.
✕Probably not a fit
People who are pregnant or actively trying to become pregnant, those unwilling or unable to start either progestin option, or those with medical contraindications to progestin therapy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter prospective observational cohort and registry enrolling about 300 post-menarcheal adolescents and young adults with or being worked up for inherited bleeding disorders who choose either an LNG-IUD or daily norethindrone acetate. The study will compare bleeding outcomes, patient-reported quality of life and satisfaction, hemostatic parameter changes, and iron repletion after six months of treatment. The primary outcome is treatment success defined as a Pictorial Blood Loss Assessment Chart (PBAC) score below 50 at six months, with multiple secondary endpoints including bleeding management measures and laboratory markers. Outcomes after LNG-IUD in participants with bleeding disorders will also be compared to a control group without a bleeding disorder.
Why it matters
Potential benefit: If successful, this could clarify which progestin option provides better bleeding control, improves iron stores, and enhances quality of life for young people with inherited bleeding disorders.
How similar studies have gone: Both the levonorgestrel IUD and oral norethindrone have shown effectiveness for heavy menstrual bleeding in people without bleeding disorders, but rigorous data in those with inherited bleeding disorders are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Stanford
Palo Alto, California, United States Recruiting -
Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting -
Children's Mercy
Kansas City, Missouri, United States Recruiting -
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
Penn State Health
Hershey, Pennsylvania, United States Recruiting -
Seattle Children's Hospital
Seattle, Washington, United States Recruiting
Show 2 more locations
-
Emory
Atlanta, Georgia, United States Not yet recruiting -
University of Michigan Medicine
Ann Arbor, Michigan, United States Not yet recruiting
Study contacts
- Principal investigator: Maureen Baldwin, MD MPH — Oregon Health and Science University
- Study coordinator: OHSU Women's Health Research Unit
- Email: whru@ohsu.edu
- Phone: 5034943666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ATHNdataset registry for people with bleeding and clotting disorders
This registry collects health, treatment, and patient-reported information from people with bleeding and clotting disorders seen at ATHN-affiliated centers to help improve care and outcomes.
-
Managing heavy menstrual bleeding in adolescents with hormonal treatments
This study is testing how well hormonal treatments can help teenagers with heavy menstrual bleeding, whether or not they have bleeding disorders.
-
Long-term observation of non-cancer blood disorders
This study is tracking people with blood disorders like hemophilia and thrombosis for at least 15 years to see how their conditions change over time and gather useful information for doctors and researchers.
-
Mother-and-child hemophilia A program
See if following pregnant people with a severe hemophilia A genotype and their children from pregnancy through early childhood can identify factors linked to maternal bleeding and the child’s development of anti‑FVIII antibodies.
-
tAN to reduce heavy menstrual bleeding (LUNA)
This trial tests whether transcutaneous auricular neurostimulation (tAN) can reduce heavy menstrual bleeding in people aged 14–45 with no known structural cause.
-
Early genomic testing to find inherited causes of bleeding
This project will test whether doing genomic testing early helps people referred to hematology with suspected inherited bleeding disorders get diagnosed sooner and more often.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.