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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heavy Menstrual Bleeding
• Intervention / Treatment: Drug: UPA; Drug: Placebo (for TEA); Drug: TEA; Drug: Placebo (for UPA)

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 1N8
      • Saskatoon Obstetric and Gynecologic Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UPA Treatment Group; UPA 5mg capsule daily + Placebo 2 capsules 4 times a day	Drug: UPA; Experimental drug; Other Names: Ulipristal Acetate; Drug: Placebo (for TEA); Sugar pill manufactured to mimic TEA 500mg
ACTIVE_COMPARATOR: TEA Treatment Group; TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily	Drug: TEA; Active comparator; Other Names: Tranexamic Acid; Drug: Placebo (for UPA); Sugar pill manufactured to mimic UPA 5 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ACTUAL): January 17, 2020

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (ESTIMATE): January 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 25, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Menstruation Disturbances; Uterine Hemorrhage; Hemorrhage; Menorrhagia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Tranexamic Acid; Ulipristal acetate
• Other Study ID Numbers: PBLL07230904; 16-155 (OTHER: University of Saskatchewan Biomedical Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No