Heavy Menstrual BleedingPhase 1NCT03027973
Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding
A Phase 1 study testing UPA and TEA in people with Heavy Menstrual Bleeding, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- UPA and TEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2020to 17 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Saskatoon Obstetric and Gynecologic Consultants
Saskatoon, Saskatchewan, S7K 1N8
About this study
Official title: 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.
Read the 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
- Being tested
- UPA, TEA, Placebo (for UPA), Placebo (for TEA)
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPADrug
Also called Ulipristal Acetate
Experimental drug
TEADrug
Also called Tranexamic Acid
Active comparator
Placebo (for UPA)Drug
Sugar pill manufactured to mimic UPA 5 mg
Placebo (for TEA)Drug
Sugar pill manufactured to mimic TEA 500mg
| Study group | Role | What they receive |
|---|---|---|
| UPA Treatment Group | Experimental | UPA 5mg capsule daily + Placebo 2 capsules 4 times a day Receives: Drug: UPA; Drug: Placebo (for TEA) |
| TEA Treatment Group | Active comparator | TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily Receives: Drug: TEA; Drug: Placebo (for UPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Baseline and repeated 3 months later
Secondary outcomes (1)
Number of adverse events that occur
The subjective change in symptoms will be assessed based on recordings in the study diaries.
Measured: From Baseline visit to end of study 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completion17 Jan 2020
Why it stopped: PI made the decision to not continue the study. It was at the Health Canada review stage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almereau Prollius, University of Saskatchewan
- Investigators
- Almereau Prollius, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027973
- Sponsor's protocol ID
- PBLL07230904
- Other IDs
- 16-155
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03027973
- Acronym / sponsor ID
- PBLL07230904
- Conditions
- Heavy Menstrual Bleeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI made the decision to not continue the study. It was at the Health Canada review stage.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UPA Treatment Group | Experimental | Drug: UPA, Drug: Placebo (for TEA)UPA 5mg capsule daily + Placebo 2 capsules 4 times a day |
| TEA Treatment Group | Active comparator | Drug: TEA, Drug: Placebo (for UPA)TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPAAlso: Ulipristal AcetateExperimental drug | Drug | UPA Treatment Group |
| TEAAlso: Tranexamic AcidActive comparator | Drug | TEA Treatment Group |
| Placebo (for UPA)Sugar pill manufactured to mimic UPA 5 mg | Drug | TEA Treatment Group |
| Placebo (for TEA)Sugar pill manufactured to mimic TEA 500mg | Drug | UPA Treatment Group |
Primary outcome
Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
Time frame: At Baseline and repeated 3 months later
The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.
1 secondary outcome
Number of adverse events that occur
Time frame: From Baseline visit to end of study 3 months later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almereau Prollius, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UPA and TEA in people with Heavy Menstrual Bleeding, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months (time frame: At Baseline and repeated 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.