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CompletedNCT01846507Updated Oct 24, 2018Results posted

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

A Phase 4 interventional study of Tranexamic Acid in Heavy Menstrual Bleeding, sponsored by Nationwide Children's Hospital. Completed at 5 sites in United States. Open to female participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Nationwide Children's Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
10 Years to 19 Years
Sex
Female
01

Study 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.

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.

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.

02

Conditions studied

  • Heavy Menstrual Bleeding

Keywords

  • Heavy Menstrual Bleeding
  • HMB
  • Lysteda
03

In context

Menorrhagia

182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Menstruating females 10-19 years of age
  2. Non-smoker
  3. Physician and patient have agreed to initiate Lysteda
  4. Diagnosis of HMB based on the medical judgment of the principal or site investigator
  5. Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period
  6. Negative pregnancy test
  7. Informed consent obtained and signed
  8. Informed assent obtained and signed
  9. Understanding of study procedures
  10. Ability to comply with study procedures for the entire length of the study
  11. 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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance
  3. 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.
  4. Pregnancy within the past 6 months and/or breast-feeding
  5. 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
  6. Use of systemic steroids within 1 month of study entry
  7. History of subarachnoid hemorrhage
  8. History of Hepatitis B, C, or HIV
  9. Baseline creatinine >20% above the upper limit of normal for age
  10. Severe anemia (hemoglobin \<8 g/dL)
  11. Systolic blood pressure \<85 or diastolic blood pressure \<55
  12. Heart rate \<50 at time of screening
  13. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Tranexamic acid

    Subjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid.

    Drug: Tranexamic Acid

Interventions

  • DrugTranexamic Acid

    Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.

    Also known as: Lysteda

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

Secondary outcomes

  1. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

  2. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

  3. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

  4. 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).

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

  5. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

  6. 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.

    Time frame: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

07

Results

Posted Jul 12, 2018
Limitations and caveats
Small sample size Subjective measurement of menstrual blood loss

Participant flow

Participant flow — Overall Study
MilestoneTranexamic Acid
Started32
Completed25
Not completed7
Withdrew: Lost to follow-up4
Withdrew: Protocol violation1
Withdrew: Missing data2

Outcome measures

PrimaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · score on a scale
Change From Baseline Menses for Participant Perceived Blood Loss
score on a scaleBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Participant Perceived Blood Loss3 (1 to 4)1.9 (1 to 4)
SecondaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · score on a scale
Change From Baseline Menses for Participant Perceived Limitation of School Attendance
score on a scaleBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Participant Perceived Limitation of School Attendance1.64 (1 to 5)1.27 (1 to 5)
SecondaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · score on a scale
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities
score on a scaleBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities2.08 (1 to 5)1.40 (1 to 5)
SecondaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · score on a scale
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities
score on a scaleBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities3.5 (1 to 5)1.76 (1 to 5)
SecondaryChange 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).

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · score on a scale
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores
score on a scaleBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores255.1 (62 to 699)154.6 (12 to 561)
SecondaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · gm/dL
Change From Baseline Menses for Hemoglobin Lab Value
gm/dLBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Hemoglobin Lab Value12.67 (10.4 to 15.3)12.84 (10.6 to 14.7)
SecondaryChange 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.

Time frame:
Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
Reported as:
Mean · ng/dL
Change From Baseline Menses for Ferritin Lab Value
ng/dLBaseline MensesTreated With Tranexamic Acid During Menses
Change From Baseline Menses for Ferritin Lab Value25.94 (4 to 82)26.34 (5 to 59)

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tranexamic Acid0/30 (0%)1/30 (3.3%)23/30 (76.7%)
Most frequent serious events
Most frequent serious events
EventTranexamic Acid
Suicidal IdeationPsychiatric disorders1/30
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTranexamic Acid
Upper respiratory infection sypmtomsInfections and infestations14/30
Musculoskeletal painMusculoskeletal and connective tissue disorders9/30
FatigueReproductive system and breast disorders6/30
Abdominal painGastrointestinal disorders6/30
HeadacheGeneral disorders5/30
DysmenorrheaReproductive system and breast disorders4/30
NauseaGastrointestinal disorders3/30
Heavy mensesReproductive system and breast disorders2/30
AnxietyPsychiatric disorders2/30
FeverInfections and infestations2/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tranexamic Acid
Mean14.7 (11 to 18)
Sex: Female, Male
Sex: Female, Male(Participants)Tranexamic Acid
Female25
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tranexamic Acid
Hispanic or Latino1
Not Hispanic or Latino24
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tranexamic Acid
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American7
White14
More than one race3
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Tranexamic Acid
United States25
08

Study locations

5 sites
  • Riley Hospital for Children at IU Health
    Indianapolis, Indiana 46202, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Akron Children's Hospital
    Akron, Ohio 44302, United States
  • Rainbow Babies & Children's Hospital
    Cleveland, Ohio 44106, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01846507
Lead sponsor
Nationwide Children's Hospital
Responsible party
Sarah O'Brien (Director of Experimental Therapeutics, Nationwide Children's Hospital) — Principal investigator
First posted
May 3, 2013
Start date
Apr 2013
Primary completion
Nov 2016
Completion
Nov 2016
Results posted
Jul 12, 2018
Last update
Oct 24, 2018

Study contacts

Sarah O'Brien, MD, MSc
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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