Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

• Status: Completed
• Trial end date: 2020-12-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shannon K. Laughlin-Tommaso
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Levonorgestrel; Tranexamic Acid

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