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

Primary Purpose

Heavy Menstrual Bleeding

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
UPA
TEA
Placebo (for UPA)
Placebo (for TEA)
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Saskatoon Obstetric and Gynecologic Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UPA Treatment Group

TEA Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of adverse events that occur
The subjective change in symptoms will be assessed based on recordings in the study diaries.

Full Information

First Posted
January 15, 2017
Last Updated
January 25, 2020
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT03027973
Brief Title
Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding
Official Title
Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI made the decision to not continue the study. It was at the Health Canada review stage.
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UPA Treatment Group
Arm Type
Experimental
Arm Description
UPA 5mg capsule daily + Placebo 2 capsules 4 times a day
Arm Title
TEA Treatment Group
Arm Type
Active Comparator
Arm Description
TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily
Intervention Type
Drug
Intervention Name(s)
UPA
Other Intervention Name(s)
Ulipristal Acetate
Intervention Description
Experimental drug
Intervention Type
Drug
Intervention Name(s)
TEA
Other Intervention Name(s)
Tranexamic Acid
Intervention Description
Active comparator
Intervention Type
Drug
Intervention Name(s)
Placebo (for UPA)
Intervention Description
Sugar pill manufactured to mimic UPA 5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo (for TEA)
Intervention Description
Sugar pill manufactured to mimic TEA 500mg
Primary Outcome Measure Information:
Title
Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
Description
The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.
Time Frame
At Baseline and repeated 3 months later
Secondary Outcome Measure Information:
Title
Number of adverse events that occur
Description
The subjective change in symptoms will be assessed based on recordings in the study diaries.
Time Frame
From Baseline visit to end of study 3 months later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almereau Prollius, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saskatoon Obstetric and Gynecologic Consultants
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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