Clinical trial NCT03317795: Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Official title: Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heavy Menstrual Bleeding
Menorrhagia
Uterine Fibroids
Keywords: Menorrhagia
FIbroids
Menstrual Bleeding
Heavy Bleeding
Menses
Uterine Fibroids
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-10-23
Enrollment: 18
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in Self-Reported Menorrhagia Scores
timeFrame: Baseline, 3 months
measure: Number of Participants to Complete Study
timeFrame: 9 months
Secondary outcomes:
measure: Change in Pain Score
timeFrame: Baseline, 3 months
measure: Change in Quality of Life
timeFrame: Baseline, 3 months
measure: Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
timeFrame: Baseline, 3 months
measure: Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
timeFrame: Baseline, 3 months
measure: Change in Fibroid Size
timeFrame: 9 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Jacksonville, Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shannon K Laughlin-Tommaso, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Christopher C Destephano, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: