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Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

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ClinicalTrials.gov Identifier: NCT01846507
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : July 12, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah O'Brien, Nationwide Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heavy Menstrual Bleeding
Intervention Drug: Tranexamic Acid
Enrollment 32
Recruitment Details  
Pre-assignment Details Baseline menses (no treatment) followed by 3 menses using tranexamic acid.
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Adolescent girls aged 10-19 years with heavy menstrual bleeding
Period Title: Overall Study
Started 32
Completed 25
Not Completed 7
Reason Not Completed
Lost to Follow-up             4
Protocol Violation             1
Missing data             2
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Tranexamic 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.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
14.7
(11 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
1
   4.0%
Not Hispanic or Latino
24
  96.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  28.0%
White
14
  56.0%
More than one race
3
  12.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title Change From Baseline Menses for Participant Perceived Blood Loss
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 25
Mean (Full Range)
Unit of Measure: score on a scale
3
(1 to 4)
1.9
(1 to 4)
2.Secondary Outcome
Title Change From Baseline Menses for Participant Perceived Limitation of School Attendance
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 25
Mean (Full Range)
Unit of Measure: score on a scale
1.64
(1 to 5)
1.27
(1 to 5)
3.Secondary Outcome
Title Change From Baseline Menses for Participant Perceived Limitation in Physical Activities
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 25
Mean (Full Range)
Unit of Measure: score on a scale
2.08
(1 to 5)
1.40
(1 to 5)
4.Secondary Outcome
Title Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 25
Mean (Full Range)
Unit of Measure: score on a scale
3.5
(1 to 5)
1.76
(1 to 5)
5.Secondary Outcome
Title Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 24 24
Mean (Full Range)
Unit of Measure: score on a scale
255.1
(62 to 699)
154.6
(12 to 561)
6.Secondary Outcome
Title Change From Baseline Menses for Hemoglobin Lab Value
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 22
Mean (Full Range)
Unit of Measure: gm/dL
12.67
(10.4 to 15.3)
12.84
(10.6 to 14.7)
7.Secondary Outcome
Title Change From Baseline Menses for Ferritin Lab Value
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Menses Treated With Tranexamic Acid During Menses
Hide Arm/Group Description:
Adolescent girls aged 10-19 years with heavy menstrual bleeding - Baseline menses with no treatment
Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Overall Number of Participants Analyzed 25 22
Mean (Full Range)
Unit of Measure: ng/dL
25.94
(4 to 82)
26.34
(5 to 59)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid
Hide Arm/Group Description Adolescent girls aged 10-19 years with heavy menstrual bleeding
All-Cause Mortality
Tranexamic Acid
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Psychiatric disorders   
Suicidal Ideation   1/30 (3.33%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tranexamic Acid
Affected / at Risk (%) # Events
Total   23/30 (76.67%)    
Gastrointestinal disorders   
Abdominal pain   6/30 (20.00%)  7
Nausea   3/30 (10.00%)  4
General disorders   
Headache   5/30 (16.67%)  7
Dizziness   2/30 (6.67%)  2
Infections and infestations   
Upper respiratory infection sypmtoms   14/30 (46.67%)  23
Fever   2/30 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain   9/30 (30.00%)  10
Psychiatric disorders   
Anxiety   2/30 (6.67%)  2
Reproductive system and breast disorders   
Fatigue   6/30 (20.00%)  8
Dysmenorrhea   4/30 (13.33%)  4
Heavy menses   2/30 (6.67%)  3
Indicates events were collected by systematic assessment
Small sample size Subjective measurement of menstrual blood loss
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sarah O'Brien, MD
Organization: Nationwide Children's Hospital
Phone: 614-722-3070
EMail: sarah.obrien@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Sarah O'Brien, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01846507     History of Changes
Other Study ID Numbers: NCH12-00822
First Submitted: May 1, 2013
First Posted: May 3, 2013
Results First Submitted: March 7, 2018
Results First Posted: July 12, 2018
Last Update Posted: October 24, 2018