Heavy Menstrual BleedingPhase 4NCT01846507
Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
A Phase 4 study testing Tranexamic Acid in people with Heavy Menstrual Bleeding, run by Nationwide Children's Hospital at 5 sites in United States.
Trial summary
This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Menstruating females 10-19 years of age
- Non-smoker
- Physician and patient have agreed to initiate Lysteda
- Diagnosis of HMB based on the medical judgment of the principal or site investigator
- Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period
- Negative pregnancy test
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- Informed consent obtained and signed
- Informed assent obtained and signed
- Understanding of study procedures
- Ability to comply with study procedures for the entire length of the study
- Subjects should be either sexually inactive (abstinent) or agree to use a barrier method with spermicide in the event of sexual activity throughout the study period
Who cannot join
- Active thromboembolic disease, history of thromboembolic disease (including retinal vein or artery occlusion), known inherited thrombophilia, or family history of thrombosis in a first degree relative
- Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance
- Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders such as type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects, and patients with bleeding due to Ehlers Danlos syndrome WILL be eligible to participate in the study.
- Pregnancy within the past 6 months and/or breast-feeding
- Use of hormonal contraception (estrogen and progestin) within 3 months of study entry, or anticipated need to initiate estrogen-containing hormonal contraception during the study period
- Use of systemic steroids within 1 month of study entry
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- History of subarachnoid hemorrhage
- History of Hepatitis B, C, or HIV
- Baseline creatinine >20% above the upper limit of normal for age
- Severe anemia (hemoglobin <8 g/dL)
- Systolic blood pressure <85 or diastolic blood pressure <55
- Heart rate <50 at time of screening
- Use of intranasal DDAVP during menses will be permitted, but only if the patient has a history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment, so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical procedures during the study period.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Akron Children's Hospital
Akron, Ohio, 44302
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life.
Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents.
Read more
Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.
The purposes of this study include:
To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life.
Lysteda has been approved by the Food and Drug Administration for use in patients > than 18 years of age but not for younger patients.
Read the detailed description
This is a multi-center (5 sites) open-label, single-arm, efficacy study of Lysteda in the treatment of adolescent females (10-19 years of age) with heavy menstrual bleeding (HMB). Each subject will receive oral Lysteda 1.3 grams three times daily during the first five days of menses. Subjects will be monitored over the course of four menstrual cycles (1 pre-treatment cycle and 3 treatment cycles). During all cycles, assessments of menstrual bleeding will be performed using the Menorrhagia Impact Questionnaire (MIQ) and Pictorial Blood Assessment Chart (PBAC).
The study will begin as a currently funded pilot study to assess the efficacy of Lysteda in 32 patients followed to study completion.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Tranexamic Acid
- Keywords
- Heavy Menstrual Bleeding, HMB, Lysteda
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Lysteda
Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Subjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Menses for Participant Perceived Blood Loss
Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Secondary outcomes (6)
Change From Baseline Menses for Participant Perceived Limitation of School Attendance
Menorrhagia Impact Questionnaire (MIQ): Question 2 - participant perceived limitation of school attendance during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being school attendance not at all limited and 5 being school attendance limited extremely). Lower values indicate a better outcome (less limitation of school attendance). Unit of measure is scores on a scale.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities
Menorrhagia Impact Questionnaire (MIQ): Question 3 - participant perceived limitation in physical activities during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being physical activities not at all limited and 5 being physical activities extremely limited). Lower values indicate a better outcome (less limitation of physical activities). Unit of measure is scores on a scale.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities
Menorrhagia Impact Questionnaire (MIQ): Question 4 - participant perceived limitation of social or leisure during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being social or leisure activities not at all limited and 5 being social or leisure activities limited extremely). Lower values indicate a better outcome (less limitation of social or leisure activities). Unit of measure is scores on a scale.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores
Pictorial Blood Assessment Chart (PBAC) scores - participant assessment of menstrual blood loss during menses using a pictorial chart to score menstrual blood loss. Pictorial scores range from 1 point for mild soaking of a pad/tampon, 5 points for moderate soaking of a pad/tampon, 10 points for severe soaking of a pad/tampon, and 5 points for each episode of flooding and for each blood clot larger than a quarter in size. Lower values indicate a better outcome (less blood loss). Unit of measure is a total computed score (all points during the menses from the pictorial chart added together).
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Hemoglobin Lab Value
Hemoglobin lab value normal range is 12 g/dL to 16 g/dL. Values in the range of 12 g/dL to 16 g/dL would be considered normal Hemoglobin values. A score lower than the normal range (below 12 g/dL) would indicate a worse outcome. Unit of measure is g/dL.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Ferritin Lab Value
Ferritin lab value normal range is 7 ng/mL to 142 ng/mL. Values in the range of 7ng/mL to 142 ng/mL would be considered normal Ferritin values. A score lower than the normal range (below 7 ng/mL) would indicate a worse outcome. Unit of measure is ng/mL.
Measured: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah O'Brien, Nationwide Children's Hospital
- Investigators
- Sarah O'Brien, MD, MSc, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846507
- Sponsor's protocol ID
- NCH12-00822
- Status last verified
- Sep 2018
- First submitted
- 1 May 2013
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT01846507
- Acronym / sponsor ID
- NCH12-00822
- Conditions
- Heavy Menstrual Bleeding
- Keywords
- Heavy Menstrual Bleeding, HMB, Lysteda
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life.
Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents.
Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.
The purposes of this study include:
To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life.
Lysteda has been approved by the Food and Drug Administration for use in patients > than 18 years of age but not for younger patients.
Detailed description
This is a multi-center (5 sites) open-label, single-arm, efficacy study of Lysteda in the treatment of adolescent females (10-19 years of age) with heavy menstrual bleeding (HMB). Each subject will receive oral Lysteda 1.3 grams three times daily during the first five days of menses. Subjects will be monitored over the course of four menstrual cycles (1 pre-treatment cycle and 3 treatment cycles). During all cycles, assessments of menstrual bleeding will be performed using the Menorrhagia Impact Questionnaire (MIQ) and Pictorial Blood Assessment Chart (PBAC).
The study will begin as a currently funded pilot study to assess the efficacy of Lysteda in 32 patients followed to study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidSubjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Menstruating females 10-19 years of age
- Non-smoker
- Physician and patient have agreed to initiate Lysteda
- Diagnosis of HMB based on the medical judgment of the principal or site investigator
- Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period
Key exclusion criteria (13 listed)
- Active thromboembolic disease, history of thromboembolic disease (including retinal vein or artery occlusion), known inherited thrombophilia, or family history of thrombosis in a first degree relative
- Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance
- Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders such as type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects, and patients with bleeding due to Ehlers Danlos syndrome WILL be eligible to participate in the study.
- Pregnancy within the past 6 months and/or breast-feeding
- Use of hormonal contraception (estrogen and progestin) within 3 months of study entry, or anticipated need to initiate estrogen-containing hormonal contraception during the study period
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 |
|---|---|---|
| Tranexamic AcidAlso: LystedaSubjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation. | Drug | Tranexamic acid |
Primary outcome
Change From Baseline Menses for Participant Perceived Blood Loss
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.
6 secondary outcomes
Change From Baseline Menses for Participant Perceived Limitation of School Attendance
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Hemoglobin Lab Value
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Change From Baseline Menses for Ferritin Lab Value
Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah O'Brien, MD, MSc principal investigator
Nationwide Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Heavy Menstrual Bleeding, run by Nationwide Children's Hospital at 5 sites in United States.
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 11 inclusion and 13 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: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Menses for Participant Perceived Blood Loss (time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid). 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 24 Oct 2018.