This study compares two treatments for the management of heavy menstrual bleeding, ulipristal acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the participants will receive UPA and a placebo, and the other half will receive TEA and a placebo.
UPA is approved by Health Canada for the treatment of signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery. UPA is considered investigational for this study, as it has not been approved by Health Canada for the treatment of heavy menstrual bleeding in women who do not have uterine fibroids. TEA is approved by Health Canada for prevention or reduction of bleeding in different conditions, including heavy periods. This treatment is available as part of routine care for regular heavy menstrual bleeding and is being used as the comparison treatment in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Saskatoon Obstetric and Gynecologic Consultants
Saskatoon, Saskatchewan, Canada
Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.
Time frame: At Baseline and repeated 3 months later
Number of adverse events that occur
The subjective change in symptoms will be assessed based on recordings in the study diaries.
Time frame: From Baseline visit to end of study 3 months later
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Sugar pill manufactured to mimic TEA 500mg