Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Completed · Phase 4

Conditions studied: Heavy Menstrual Bleeding, Menorrhagia, Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT03317795

Run by

Shannon K. Laughlin-Tommaso

People needed

18

Starts

2017-11-14

Expected to finish

2020-12-28

Last updated by the study team

2021-12-08

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Jacksonville, Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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