Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Jun 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well two hormonal treatments work for young women who experience heavy menstrual bleeding and have bleeding disorders, such as Von Willebrand Disease. The two treatments being compared are the levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). The goal is to see how these treatments affect bleeding, overall satisfaction, and quality of life over six months. Researchers will also look at how the results from these young women compare to those without a bleeding disorder.

Eligible participants are girls and young women aged 10 to 24 who have heavy menstrual bleeding and a bleeding disorder or have been tested for one. To join, they must be able to give consent. The trial is currently not recruiting participants, but once it begins, those who participate will be monitored for six months to evaluate the effectiveness and safety of the treatments. This study aims to improve understanding of how these treatments can help manage heavy menstrual bleeding in this specific group.

Gender

FEMALE

Eligibility 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