Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Menorrhagia; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Levonorgestrel IUS; Tranexamic Acid
Intervention description: 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.
Intervention MeSH terms: Tranexamic Acid; Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Menorrhagia; FIbroids; Menstrual Bleeding; Heavy Bleeding; Menses; Uterine Fibroids

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women ages 25 -50

          -  Monthly menses

          -  Image-confirmed uterine fibroids of at least 1 cm in size, either submucosal or
             intramural

          -  Seeking treatment for heavy menstrual bleeding following completed clinical evaluation

          -  Self-reported heavy menstrual bleeding for three months or longer

          -  Completed evaluation for heavy menstrual bleeding within one year of study enrollment

          -  Understands the English language for consent and questionnaires

          -  Able and willing to provide informed consent

        Exclusion Criteria:

          -  Class 0 fibroids confirmed by hysteroscopy, saline-infused sonogram, or 3D ultrasound

          -  Uterine sounding length ≥ 14 cm

          -  Uterine size ≥ 20 weeks gestational size

          -  Abnormal endometrial biopsy or incomplete clinical testing to rule out malignancy

          -  Needs or is using hormonal contraception, including estrogen-containing medications

          -  Venous thromboembolic history, clotting disorder, or strong family history of venous
             thromboembolic events

          -  Breast, uterine, or cervical malignancy

          -  Liver disease or liver tumor

          -  Pelvic inflammatory disease, gonorrhea or chlamydia infection during the past three
             months

          -  Hemoglobin < 8 mg/dL. For women with hemoglobin 8.0 - 12.0 mg/dL, iron supplement is
             recommended

          -  Serum creatinine ≥ 1.4

          -  Current pregnancy or currently lactating