Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317795
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Shannon K. Laughlin-Tommaso, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE November 14, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • Change in Self-Reported Menorrhagia Scores [ Time Frame: Baseline, Month 6 ]
    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).
  • Duration of Use of Assigned Treatment [ Time Frame: Approximately up to 5 years ]
    The duration of use of either tranexamic acid or the levonorgestrel intrauterine system will be measured in days.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03317795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • Mean Fibroid Size [ Time Frame: Month 9 following initiation of treatment ]
    Fibroid size will be reported as centimeters (cm).
  • Change in Pain Score [ Time Frame: Baseline, Month 9 ]
    Pain will be measured by a 10 cm visual analog scale (VAS), with one end of the scale 0 indicating no pain, and the other end 10 indicating worst pain ever.
  • Change in Quality of Life, as measured by the Rand Corporation (RAND) 36-Item Health Survey [ Time Frame: Baseline, Month 9 ]
    The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. A high score defines a more favorable health state. The total score is on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
  • Change in Quality of Life, as measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) [ Time Frame: Baseline, Month 9 ]
    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) [ Time Frame: Baseline, Month 9 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Official Title  ICMJE Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heavy Menstrual Bleeding
  • Menorrhagia
  • Uterine Fibroids
Intervention  ICMJE
  • 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.
    Other Name: Mirena IUS
  • Drug: 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.
    Other Name: Lysteda
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Levonorgestrel IUS
  • 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).
    Intervention: Drug: Tranexamic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2017)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marnie M Wetzstein, PhD, RN 507-266-4813 wetzstein.marnie@mayo.edu
Contact: Maureen A. Lemens, BSN, RN 507-293-1487 lemens.maureen@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317795
Other Study ID Numbers  ICMJE 16-008671
R21HD091337 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shannon K. Laughlin-Tommaso, Mayo Clinic
Study Sponsor  ICMJE Shannon K. Laughlin-Tommaso
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Shannon K Laughlin-Tommaso, MD, MPH Mayo Clinic
Principal Investigator: Christopher C Destephano, MD, MPH Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP