Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change in Self-Reported Menorrhagia Scores
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Levonorgestrel IUS (Drug)
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).
Intervention: Tranexamic Acid (Drug)
Outcomes
Primary Outcomes
Change in Self-Reported Menorrhagia Scores
Time Frame: Baseline, 3 months
The Menorrhagia Multi-Attribute Scale (MMAS) questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).
Number of Participants to Complete Study
Time Frame: 9 months
Total number of study participants to complete assigned treatment.
Secondary Outcomes
- Change in Fibroid Size(9 months)
- Change in Quality of Life(Baseline, 3 months)
- Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)(Baseline, 3 months)
- Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)(Baseline, 3 months)
- Change in Pain Score(Baseline, 3 months)
Investigators
Shannon K. Laughlin-Tommaso
Associate Professor of Obstetrics and Gynecology
Mayo Clinic