Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Shannon K. Laughlin-Tommaso

Status and phase: Completed; Phase 4

Conditions: Uterine Fibroids; Menorrhagia; Heavy Menstrual Bleeding

Treatments: Drug: Tranexamic Acid; Drug: Levonorgestrel IUS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03317795

16-008671

R21HD091337 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 18 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Levonorgestrel IUS

Active Comparator group

Description:

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.

Treatment:

Drug: Levonorgestrel IUS

Tranexamic Acid

Active Comparator group

Description:

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).

Treatment:

Drug: Tranexamic Acid