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

NCT03027973 | Withdrawn Phase 1

• 2 other identifiers: PBLL0723090416-155
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of adverse events that occur

  From Baseline visit to end of study 3 months later

Study Arms (2)

UPA Treatment Group

EXPERIMENTAL

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

Drug: UPA; Drug: Placebo (for TEA)

TEA Treatment Group

ACTIVE COMPARATOR

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

Drug: TEA; Drug: Placebo (for UPA)

Interventions

UPA DRUG

Experimental drug

Also known as: Ulipristal Acetate

UPA Treatment Group

TEA DRUG

Active comparator

Also known as: Tranexamic Acid

TEA Treatment Group

Placebo (for UPA) DRUG

Sugar pill manufactured to mimic UPA 5 mg

TEA Treatment Group

Placebo (for TEA) DRUG

Sugar pill manufactured to mimic TEA 500mg

UPA Treatment Group

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon Obstetric and Gynecologic Consultants

Saskatoon, Saskatchewan, S7K 1N8, Canada

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

ulipristal acetate; Tea; Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Almereau Prollius, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2020
• Study Completion: January 17, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)