NCT03027973

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	UPA	Experimental drug
DRUG	TEA	Active comparator
DRUG	Placebo (for UPA)	Sugar pill manufactured to mimic UPA 5 mg
DRUG	Placebo (for TEA)	Sugar pill manufactured to mimic TEA 500mg

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-17
• First posted: 2017-01-23
• Last updated: 2020-01-28

Locations

1 site across 1 country: Canada