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

NCT ID: NCT03027973

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-01-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UPA Treatment Group

UPA 5mg capsule daily + Placebo 2 capsules 4 times a day

Group Type: EXPERIMENTAL

UPA

Intervention Type: DRUG

Experimental drug

Placebo (for TEA)

Intervention Type: DRUG

Sugar pill manufactured to mimic TEA 500mg

TEA Treatment Group

TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily

Group Type: ACTIVE_COMPARATOR

TEA

Intervention Type: DRUG

Active comparator

Placebo (for UPA)

Intervention Type: DRUG

Sugar pill manufactured to mimic UPA 5 mg

Interventions

UPA

Experimental drug

Intervention Type: DRUG

TEA

Active comparator

Intervention Type: DRUG

Placebo (for UPA)

Sugar pill manufactured to mimic UPA 5 mg

Intervention Type: DRUG

Placebo (for TEA)

Sugar pill manufactured to mimic TEA 500mg

Intervention Type: DRUG

Other Intervention Names

Ulipristal Acetate; Tranexamic Acid

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Almereau Prollius

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Almereau Prollius, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Saskatoon Obstetric and Gynecologic Consultants

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

16-155

Identifier Type: OTHER

Identifier Source: secondary_id

PBLL07230904

Identifier Type: -

Identifier Source: org_study_id