Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317795
• Other study ID #: 16-008671
• Secondary ID: R21HD091337
• Status: Completed
• Phase: Phase 4
• Start date: November 14, 2017
• Est. completion date: December 28, 2020

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Jacksonville, Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Shannon K. Laughlin-Tommaso	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-Reported Menorrhagia Scores	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).	Baseline, 3 months
Primary	Number of Participants to Complete Study	Total number of study participants to complete assigned treatment.	9 months
Secondary	Change in Pain Score	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.	Baseline, 3 months
Secondary	Change in Quality of Life	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.	Baseline, 3 months
Secondary	Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	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.	Baseline, 3 months
Secondary	Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	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.	Baseline, 3 months
Secondary	Change in Fibroid Size	Fibroid size will be reported as millimeters (mm).	9 months

External Links

•   Mayo Clinic Clinical Trials