Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Oregon Health and Science University
Summary
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.
Description
Heavy menstrual bleeding (HMB) is common among adolescents and young adults with an inherited bleeding disorder (BD) and negatively impacts health-related quality of life and physical and mental health status. Effective treatment options are available that decrease bleeding and improve quality of life, but were not studied in those with BD, so investigators do not know if there is similar effectiveness in this condition. The impact of treatment on diagnostic testing for BD or on improvement of iron deficiency is also not known. Given these gaps in knowledge, the primary objective of the Heavy…
Eligibility
- Age range
- 10–24 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- DrugLevonorgestrel Intrauterine System
52 mg levonorgestrel intrauterine system
- DrugNorethindrone Acetate
norethindrone acetate 5 mg daily
Locations (9)
- StanfordPalo Alto, California
- Colorado Anschutz Medical CampusAurora, Colorado
- EmoryAtlanta, Georgia
- University of Michigan MedicineAnn Arbor, Michigan
- Children's MercyKansas City, Missouri
- Oregon Health & Science UniversityPortland, Oregon