Trial Outcomes & Findings for Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding (NCT NCT01846507)

NCT ID: NCT01846507

Last Updated: 2018-10-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid
• Results posted on: 2018-10-24

Participant Flow

Baseline menses (no treatment) followed by 3 menses using tranexamic acid.

Participant milestones

Measure	Tranexamic Acid Adolescent girls aged 10-19 years with heavy menstrual bleeding
Overall Study STARTED	32
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Tranexamic Acid Adolescent girls aged 10-19 years with heavy menstrual bleeding
Overall Study Lost to Follow-up	4
Overall Study Protocol Violation	1
Overall Study Missing data	2

Baseline Characteristics

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

Baseline characteristics by cohort

Measure	Tranexamic Acid n=25 Participants 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.
Age, Continuous	14.7 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=25 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Participant Perceived Blood Loss	3 score on a scale Interval 1.0 to 4.0	1.9 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

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

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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=25 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Participant Perceived Limitation of School Attendance	1.64 score on a scale Interval 1.0 to 5.0	1.27 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

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

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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=25 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities	2.08 score on a scale Interval 1.0 to 5.0	1.40 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

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

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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=25 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities	3.5 score on a scale Interval 1.0 to 5.0	1.76 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

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

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).

Outcome measures

Measure	Baseline Menses n=24 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=24 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores	255.1 score on a scale Interval 62.0 to 699.0	154.6 score on a scale Interval 12.0 to 561.0

SECONDARY outcome

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

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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=22 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Hemoglobin Lab Value	12.67 gm/dL Interval 10.4 to 15.3	12.84 gm/dL Interval 10.6 to 14.7

SECONDARY outcome

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

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.

Outcome measures

Measure	Baseline Menses n=25 Participants Adolescent girls aged 10-19 with heavy menstrual bleeding - Baseline menses with no treatment	Treated With Tranexamic Acid During Menses n=22 Participants Adolescent girls aged 10-19 years with heavy menstrual bleeding - treatment with Tranexamic Acid for 3 menses
Change From Baseline Menses for Ferritin Lab Value	25.94 ng/dL Interval 4.0 to 82.0	26.34 ng/dL Interval 5.0 to 59.0

Adverse Events

Tranexamic Acid

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic Acid n=30 participants at risk Adolescent girls aged 10-19 years with heavy menstrual bleeding
Psychiatric disorders Suicidal Ideation	3.3% 1/30 • Number of events 2 • 6 months

Other adverse events

Measure	Tranexamic Acid n=30 participants at risk Adolescent girls aged 10-19 years with heavy menstrual bleeding
Reproductive system and breast disorders Fatigue	20.0% 6/30 • Number of events 8 • 6 months
General disorders Headache	16.7% 5/30 • Number of events 7 • 6 months
Infections and infestations Upper respiratory infection sypmtoms	46.7% 14/30 • Number of events 23 • 6 months
Reproductive system and breast disorders Dysmenorrhea	13.3% 4/30 • Number of events 4 • 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	30.0% 9/30 • Number of events 10 • 6 months
Gastrointestinal disorders Abdominal pain	20.0% 6/30 • Number of events 7 • 6 months
Reproductive system and breast disorders Heavy menses	6.7% 2/30 • Number of events 3 • 6 months
Psychiatric disorders Anxiety	6.7% 2/30 • Number of events 2 • 6 months
Infections and infestations Fever	6.7% 2/30 • Number of events 2 • 6 months
Gastrointestinal disorders Nausea	10.0% 3/30 • Number of events 4 • 6 months
General disorders Dizziness	6.7% 2/30 • Number of events 2 • 6 months

Additional Information

Sarah O'Brien, MD

Nationwide Children's Hospital

Phone: 614-722-3070

Email: sarah.obrien@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place