- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03317795
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic in Jacksonville, Florida
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester, Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
Other Names:
|
Active Comparator: 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).
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, 3 months
|
Number of Participants to Complete Study
Time Frame: 9 months
|
Total number of study participants to complete assigned treatment.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Score
Time Frame: 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.
|
Baseline, 3 months
|
Change in Quality of Life
Time Frame: 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.
|
Baseline, 3 months
|
Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
Time Frame: 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.
|
Baseline, 3 months
|
Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
Time Frame: 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.
|
Baseline, 3 months
|
Change in Fibroid Size
Time Frame: 9 months
|
Fibroid size will be reported as millimeters (mm).
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shannon K Laughlin-Tommaso, MD, MPH, Mayo Clinic
- Principal Investigator: Christopher C Destephano, MD, MPH, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Uterine Diseases
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Menstruation Disturbances
- Neoplasms, Muscle Tissue
- Uterine Hemorrhage
- Hemorrhage
- Leiomyoma
- Myofibroma
- Menorrhagia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Levonorgestrel
- Tranexamic Acid
Other Study ID Numbers
- 16-008671
- R21HD091337 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Fibroids
-
IceCure Medical Ltd.Withdrawn
-
The Cleveland ClinicCompletedUterine Fibroids, Menorrhagia, EndometriosisUnited States
-
Trieu, Nguyen Thi, M.D.Completed
-
Elizabeth A. StewartCompletedUterine Fibroids | Myomas | Uterine Leiomyomas | FibroidsUnited States
-
Instituto Valenciano de Infertilidad, IVI VALENCIATerminated
-
Acessa Health, Inc.Active, not recruiting
-
Mayo ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedUterine Fibroids | Myomas | Fibroids | Symptomatic Uterine LeiomyomasUnited States
-
InSightecTerminatedUterine Fibroids, With Unexplained InfertilityUnited States
-
AbbVieEnrolling by invitation
-
Mirabilis Medica, Inc.CompletedUterine Fibroids (Leiomyomas)Mexico
Clinical Trials on Levonorgestrel IUS
-
BayerCompletedContraceptionSweden, Finland, Hungary, Norway, United Kingdom
-
Oregon Health and Science UniversitySociety of Family PlanningTerminated
-
University of North Carolina, Chapel HillCompletedUnplanned PregnancyUnited States
-
Columbia UniversityBayerCompletedEpilepsy | ContraceptionUnited States
-
BayerCompletedMenorrhagia, DysmenorrheaJapan
-
BayerCompletedContraceptionChina, Korea, Republic of, Australia
-
Boston UniversityUniversity of UtahCompletedMedical Abortion | Induced Abortion | Intrauterine Device ExpulsionUnited States
-
BayerCompletedIdiopathic MenorrhagiaCroatia, Saudi Arabia, Bulgaria, Jordan, Romania, Russian Federation, Turkey, United Arab Emirates, Kuwait, India, Pakistan, Serbia, Sri Lanka