Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Phase 4

Completed

Conditions: Heavy Menstrual Bleeding
Menorrhagia
Uterine Fibroids

Interventions: Drug: Levonorgestrel IUS
Drug: Tranexamic Acid

Registration Number: NCT03317795

Lead Sponsor: Shannon K. Laughlin-Tommaso

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 18

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel IUS	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.
Tranexamic Acid	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).

Primary Outcome Measures

Name	Time	Method
Change in Self-Reported Menorrhagia Scores	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	9 months	Total number of study participants to complete assigned treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Fibroid Size	9 months	Fibroid size will be reported as millimeters (mm).
Change in Quality of Life	Baseline, 3 months	Measured by the RAND 36-Item Health Survey (Version 1.0). Physical function and mental well-being on scale range from 0-100. A high score defines a more favorable health state.
Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	Baseline, 3 months	The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher HRQL subscale scores indicate better HRQL.
Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	Baseline, 3 months	The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher Symptom Severity scores indicating greater symptoms.
Change in Pain Score	Baseline, 3 months	Pain will be measured by a 10 cm visual analog scale (VAS) which uses a 100 point score, with 0 indicating no pain and 100 indicating worst pain ever. Change was determine by subtracting the 3 month score from baseline, a negative score indicates a decrease in pain.

Trial Locations

Locations (2): Mayo Clinic in Jacksonville, Florida
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Jacksonville, Florida, United States
Mayo Clinic in Rochester, Minnesota
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Rochester, Minnesota, United States