Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Menorrhagia; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized controlled trial (RCT) to assess the comparative effectiveness of
      Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of
      heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.
    

Detailed description: 
      Uterine fibroids are common and debilitating problem for some women. Nearly 60% of women with
      fibroids report that symptoms affect their quality of life and impede physical activity, and
      24% report that fibroid symptoms prevent them from reaching their true potential at work.
      Heavy menstrual bleeding, the most common symptom of uterine fibroids, affects approximately
      1.4 million women per year.

      Medical therapy is the first line treatment for heavy menstrual bleeding, but further studies
      need to be done to prove the effectiveness of these treatments.

      The goal of this study is to determine the effectiveness of non-estrogenic medical therapy in
      women with a range of fibroid sizes, locations, and number.

      Two effective medical treatments for heavy menstrual bleeding have limited data in women with
      fibroids. The Levonorgestrel intrauterine system was FDA approved for the treatment of heavy
      menstrual bleeding in 2009 and is highly effective for decreasing menstrual bleeding,
      treating anemia and improving quality of life. Moreover, it can be used continuously for 5
      years. Tranexamic Acid is widely used outside the U.S. and was also FDA approved for heavy
      menstrual bleeding in 2009. Tranexamic Acid reduces menstrual blood loss in 40% of women and
      improves quality of life. In women with fibroids, Tranexamic Acid has been shown to decrease
      heavy menstrual bleeding and cause necrosis of the fibroids, especially larger fibroids,
      which should improve its efficacy for women with fibroids.

      This randomized controlled trial will assess the comparative effectiveness of Levonorgestrel
      intrauterine system to Tranexamic Acid for the treatment of heavy menstrual bleeding in women
      with uterine fibroids
    

Intervention name(s): Levonorgestrel IUS; Tranexamic Acid
Intervention type(s): Drug; Drug
Intervention description(s): 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 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.
Other intervention name(s): Mirena IUS; Lysteda
Intervention MeSH terms: Tranexamic Acid; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; FIbroids; Menstrual Bleeding; Heavy Bleeding; Menses; Uterine Fibroids