Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT03317795|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heavy Menstrual Bleeding Menorrhagia Uterine Fibroids||Drug: Levonorgestrel IUS Drug: Tranexamic Acid||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids|
|Actual Study Start Date :||November 14, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
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
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).
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317795
|Contact: Marnie M Wetzstein, PhD, RNemail@example.com|
|Contact: Maureen A. Lemens, BSN, RNfirstname.lastname@example.org|
|United States, Florida|
|Mayo Clinic in Jacksonville, Florida||Active, not recruiting|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester, Minnesota||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Maureen A Lemens, BSN, RN 507-293-1487 email@example.com|
|Principal Investigator: Shannon K Laughlin-Tommaso, MD, MPH|
|Principal Investigator:||Shannon K Laughlin-Tommaso, MD, MPH||Mayo Clinic|
|Principal Investigator:||Christopher C Destephano, MD, MPH||Mayo Clinic Florida|