Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial

Conditions
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Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: UPA
* Drug: TEA
* Drug: Placebo (for UPA)
* Drug: Placebo (for TEA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are female and have a uterus Participants are between the ages of 18 and 51 years at the time of consent Participants have heavy menstrual bleeding as evidenced by their symptoms of subjective increased bleeding volume and desire to seek treatment The symptom of heavy menstrual bleeding has been present for most of the last 6 months Participants have regular menstrual cycles between 24 -38 days in length Exclusion Criteria: Participants who are pregnant or have a positive urine β-hCG Participants whose bleeding is coming from a cervical, vaginal, urinary or gastrointestinal source Participants who are found to have or who have a previous diagnosis of uterine or cervical polyps, adenomyosis, or leiomyomas (fibroids) Participants who are found to have or who have had endometrial hyperplasia, cervical dysplasia or malignancy of any of the vulva, cervix, endometrium, breast or ovaries. Participants who have ovulatory dysfunction as defined by menstrual cycles that are irregular in frequency and regularity and are often punctuated with periods of amenorrhea Participants who are found to have or who have been diagnosed with a coagulopathy Participants who have a current genitourinary infection Participants who are desirous of becoming pregnant within the next four months Participants who have untreated or inadequately treated thyroid disease Participants who have a contraindication to either treatment including hypersensitivity Participants who are breastfeeding Participants with mild, moderate or severe hepatic impairment Participants with moderate or severe renal impairment Participants with severe asthma not controlled with oral glucocorticoids Participants with active disease, or history of deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral thrombosis or with family history of thromboembolic disease Patients with subarachnoid hemorrhage Patients with acquired disturbances of colour vision Participants who are already on hormone based treatment including, progesterone only pills, combined oral contraceptive pill (COCP), Intrauterine System (IUS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UPA Treatment Group<br>UPA 5mg capsule daily + Placebo 2 capsules 4 times a day | Drug: UPA<br>* Experimental drug<br>* Other names: Ulipristal Acetate;Drug: Placebo (for TEA)<br>* Sugar pill manufactured to mimic TEA 500mg<br>|
| Active Comparator: TEA Treatment Group<br>TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily | Drug: TEA<br>* Active comparator<br>* Other names: Tranexamic Acid;Drug: Placebo (for UPA)<br>* Sugar pill manufactured to mimic UPA 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Baseline and repeated 3 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events that occur | The subjective change in symptoms will be assessed based on recordings in the study diaries. | From Baseline visit to end of study 3 months later |