Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01846507

Enrollment

Registered

2013-05-03

Start date

2013-04-30

Completion date

2016-11-30

Last updated

2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Menstrual Bleeding

Keywords

Heavy Menstrual Bleeding, HMB, Lysteda

Brief 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.

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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

10 Years to 19 Years

Healthy volunteers

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

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline Menses for Participant Perceived Blood Loss	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.

Secondary

Measure	Time frame	Description
Change From Baseline Menses for Participant Perceived Limitation in Physical Activities	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.
Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities	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.
Change From Baseline Menses for Participant Perceived Limitation of School Attendance	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.
Change From Baseline Menses for Hemoglobin Lab Value	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.
Change From Baseline Menses for Ferritin Lab Value	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.
Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores	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).

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
Tranexamic Acid 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.	25
Total	25

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	4
Overall Study	Missing data	2
Overall Study	Protocol Violation	1

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	23 / 30
serious Total, serious adverse events	1 / 30

Outcome results

Primary

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.