Progestin options for heavy periods in young people with inherited bleeding disorders
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 10 Years to 24 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 9 sites (Palo Alto, California and 8 other locations) |
| Trial ID | NCT05916469 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Palo Alto, California and 8 other locations
- Stanford — Palo Alto, California, United States (Not_yet_recruiting)
- Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Not_yet_recruiting)
- Emory — Atlanta, Georgia, United States (Not_yet_recruiting)
- University of Michigan Medicine — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Children's Mercy — Kansas City, Missouri, United States (Not_yet_recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Penn State Health — Hershey, Pennsylvania, United States (Not_yet_recruiting)
- University of Washington — Seattle, Washington, United States (Not_yet_recruiting)
- Seattle Children's Hospital — Seattle, Washington, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.