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

• Status: Withdrawn
• Trial end date: 2020-01-17
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Tranexamic Acid; Ulipristal acetate

Criteria

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)