18
Participants
Start Date
November 14, 2017
Primary Completion Date
December 28, 2020
Study Completion Date
December 28, 2020
Levonorgestrel IUS
LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density.
Tranexamic Acid
Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period.
Mayo Clinic in Jacksonville, Florida, Jacksonville
Mayo Clinic in Rochester, Minnesota, Rochester
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Shannon K. Laughlin-Tommaso
OTHER