Why fibroids cause heavy bleeding

Our recent work has confirmed that fibroids are derived from a single uterine cell that abnormally divides and differentiates into a multi-cellular benign tumour. Our research also suggests that the heavy menstrual bleeding associated with uterine fibroids may be regulated by different mechanisms from bleeding in women without uterine fibroids. We have a unique opportunity to utilise a new minimally invasive therapy for symptomatic uterine fibroids called Magnetic Resonance guided Focused Ultrasound MRgFUS for fibroid-related research.

This treatment is used to identify and treat individual uterine fibroids. Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Uterine fibroids are common and debilitating problem for some women. Heavy menstrual bleeding, the most common symptom of uterine fibroids, affects approximately 1. 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 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.

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.

Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years. 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 will be dosed at mg 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 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 mg to be taken three times per day for up to 5 days of the menstrual period. 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 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.

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. It also includes a single item that provides an indication of perceived change in health. A high score defines a more favorable health state. Erratic ovulation — the release of eggs from the ovaries — may result in hormonal changes that cause the lining of the uterus the endometrium to become thicker than usual, so when it sloughs off, the menstrual bleeding is heavier and more prolonged than women are used to.

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