Phase 4 N=32 Treatment

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

Heavy Menstrual Bleeding

Bottom Line

View on ClinicalTrials.gov: NCT01846507 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jul 2018

Primary outcome: Primary: Change From Baseline Menses for Participant Perceived Blood Loss — 3; 1.9 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: Female
Sponsor: Nationwide Children's Hospital
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Menses for Participant Perceived Blood Loss	3; 1.9	—
SECONDARY Change From Baseline Menses for Participant Perceived Limitation of School Attendance	1.64; 1.27	—
SECONDARY Change From Baseline Menses for Participant Perceived Limitation in Physical Activities	2.08; 1.40	—
SECONDARY Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities	3.5; 1.76	—
SECONDARY Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores	255.1; 154.6	—
SECONDARY Change From Baseline Menses for Hemoglobin Lab Value	12.67; 12.84	—
SECONDARY Change From Baseline Menses for Ferritin Lab Value	25.94; 26.34	—

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.

Eligibility Criteria

Inclusion Criteria

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
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

Exclusion Criteria

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01846507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.