Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

PHASE4CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 14, 2017

Primary Completion Date

December 28, 2020

Study Completion Date

December 28, 2020

Conditions
Heavy Menstrual BleedingMenorrhagiaUterine Fibroids
Interventions
DRUG

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.

DRUG

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.

Trial Locations (2)

32224

Mayo Clinic in Jacksonville, Florida, Jacksonville

55905

Mayo Clinic in Rochester, Minnesota, Rochester

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Shannon K. Laughlin-Tommaso

OTHER

NCT03317795 - Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids | Biotech Hunter | Biotech Hunter