Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Heavy Menstrual Bleeding, Menorrhagia, Uterine Fibroids
About this trial
This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring Menorrhagia, FIbroids, Menstrual Bleeding, Heavy Bleeding, Menses, Uterine 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
Sites / Locations
- Mayo Clinic in Jacksonville, Florida
- Mayo Clinic in Rochester, Minnesota
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Levonorgestrel IUS
Tranexamic Acid
Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.
Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).