Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01846507
Recruitment Status : Active, not recruiting
First Posted : May 3, 2013
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):
Sarah O'Brien, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Drug: Tranexamic Acid Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
Study Start Date : April 2013
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: tranexamic acid 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

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
    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 :
  1. Menstrual blood loss, change in hemoglobin, and ferritin concentrations. [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01846507

United States, Indiana
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44302
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Principal Investigator: Sarah O'Brien, MD, MSc Nationwide Children's Hospital

Responsible Party: Sarah O'Brien, Director of Experimental Therapeutics, Nationwide Children's Hospital Identifier: NCT01846507     History of Changes
Other Study ID Numbers: NCH12-00822
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Sarah O'Brien, Nationwide Children's Hospital:
Heavy Menstrual Bleeding

Additional relevant MeSH terms:
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action