Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

NCT ID: NCT03317795

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2020-12-28

Brief 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.

Detailed 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

Conditions

Heavy Menstrual Bleeding; Menorrhagia; Uterine Fibroids

Keywords

Menorrhagia; FIbroids; Menstrual Bleeding; Heavy Bleeding; Menses; Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levonorgestrel IUS

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.

Group Type: ACTIVE_COMPARATOR

Levonorgestrel IUS

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

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.

Interventions

Levonorgestrel IUS

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.

Intervention Type: DRUG

Tranexamic Acid

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 Type: DRUG

Other Intervention Names

Mirena IUS; Lysteda

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Shannon K. Laughlin-Tommaso

OTHER

Sponsor Role: lead

Responsible Party

Shannon K. Laughlin-Tommaso

Associate Professor of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shannon K Laughlin-Tommaso, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Christopher C Destephano, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Jacksonville, Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

R21HD091337

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-008671

Identifier Type: -

Identifier Source: org_study_id