Prospective Randomized Trial of Tranexamic Acid versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women with Uterine Fibroids

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT This randomized, controlled trial seeks to determine the effectiveness of two common medications for the treatment of heavy menstrual bleeding in women with uterine fibroids. Uterine fibroids are benign tumors of the uterus that affect 30% of women during their reproductive years. These tumors are the leading cause of heavy menstrual bleeding and the most common reason for hysterectomy; nearly 200,000 hysterectomies are performed for fibroids in the U.S. every year. Women with fibroids are not traditionally included in randomized medical therapy trials for heavy menstrual bleeding. This study will compare the levonorgestrel intrauterine system to tranexamic acid, an oral medication taken only during menses. Both treatments offer non-estrogen containing medications to reduce risk in women over 35. The results of this work will be clinically significant to providing evidence for decision making and options other than hysterectomy. Our proposal is innovative in that it will extend these medicines to women with fibroids and explore the type of fibroids for which these medications are effective. The following specific aims will be pursued over the next two years: Aim 1 is designed to compare the effectiveness of levonorgestrel intrauterine system to tranexamic acid for heavy menstrual bleeding in women with uterine fibroids using patient reported satisfaction outcomes and duration of use; Aim 2 is designed to determine the patient and fibroid characteristics associated with success of these medications. The Agency for Healthcare Research and Quality (AHRQ) report in 2007 on uterine fibroids recommend that ?high priority should be given to performing randomized trials of the effectiveness of commonly used medical treatments compared with placebo and with each other for the treatment of specific symptoms.? This proposal will meet this gap in knowledge and provide further options for women with uterine fibroids.