Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Nationwide Children's Hospital
Information provided by (Responsible Party):
Sarah O'Brien, Nationwide Children's Hospital Identifier:
First received: May 1, 2013
Last updated: June 17, 2015
Last verified: June 2015

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.

Condition Intervention Phase
Heavy Menstrual Bleeding
Drug: Tranexamic Acid
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

Resource links provided by NLM:

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in health-related quality of life as defined by a ≥1 point increase in the total Menorrhagia Impact Questionnaire (MIQ) score.

Secondary Outcome Measures:
  • Menstrual blood loss, change in hemoglobin, and ferritin concentrations. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    1) Change in menstrual blood loss as measured by Pictorial Blood Assessment Chart (PBAC) scores, 2) change in hemoglobin, and 3) change in ferritin concentrations.

Estimated Enrollment: 32
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
    Other Name: Lysteda
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.


Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01846507

Contact: Heidi Ziegler, RN 614-722-3883

United States, Indiana
Riley Hospital for Children at IU Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shannon Maraldo    317-948-3395   
Principal Investigator: Kerry Hege, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Sara Streeter    816-302-6869   
Principal Investigator: Shannon Carpenter, MD MS         
United States, Ohio
Akron Children's Hospital Completed
Akron, Ohio, United States, 44302
Rainbow Babies & Children's Hospital Completed
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Heidi Ziegler, RN    614-722-3883   
Principal Investigator: Sarah O'Brien, MD, MSc         
Sponsors and Collaborators
Nationwide Children's Hospital
Principal Investigator: Sarah O'Brien, MD, MSc Nationwide Children's Hospital
  More Information

Responsible Party: Sarah O'Brien, Director of Experimental Therapeutics, Nationwide Children's Hospital Identifier: NCT01846507     History of Changes
Other Study ID Numbers: NCH12-00822 
Study First Received: May 1, 2013
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
Heavy Menstrual Bleeding

Additional relevant MeSH terms:
Menstruation Disturbances
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016