Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

This study is currently recruiting participants.
Verified May 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Sarah O'Brien, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01846507
First received: May 1, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 the age group that we will be looking at in this study.


Condition Intervention Phase
Heavy Menstrual Bleeding
Drug: Tranxemic 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: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tranxemic 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 (3 sites) open-label, single-arm, efficacy study of Lysteda in the treatment of adolescent females (12-17.99 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. If the pilot study is successful and funding is available, additional subjects will be enrolled and followed to completion, with the intent to also enroll a comparison group of young women initiating hormonal contraception to treat HMB.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12 to 17 years
  2. Post-menarcheal non-smoking females
  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 known chronic disease with an intrinsic risk of thrombosis
  2. Clinical evidence of any significant chronic illness, including cardiovascular, renal, neurologic, hepatic, endocrine, gastric, central nervous system, or psychiatric, which could affect the efficacy or safety of Lysteda, or the ability to complete study procedures. Some examples of chronic illnesses would include have a history of severe uncontrolled hypertension, uncotrolled diabetes, and cardiac arrythmias.
  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. Severe bleeding disorders that would exclude a patient would include dysfibrinogenemiz, Bernard Salier Syndrome, and Glanzmann thrombasthemia
  4. Pregnancy within the past 6 months
  5. Use of hormonal contraception (estrogen or progestin) within 3 months of study entry, or anticipated need to initiate 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. Blood pressure <90/60 or heart rate <50 at time of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846507

Contacts
Contact: Heidi Ziegler, RN 614-722-3883 heidi.ziegler@nationwidechildrens.org

Locations
United States, Ohio
Akron Children's Hospital Not yet recruiting
Akron, Ohio, United States, 44302
Contact: Ali Dawn    330-543-3805    dali@chmca.org   
Principal Investigator: Stephanie Savelli, MD         
Rainbow Babies & Children's Hospital Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Janet Martin, RN    216-844-6127    janet.martin@uhhospitals.org   
Principal Investigator: Sanjay Ahuja, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Heidi Ziegler, RN    614-722-3883    heidi.ziegler@nationwidechildrens.org   
Principal Investigator: Sarah O'Brien, MD, MSc         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Sarah O'Brien, MD, MSc Nationwide Children's Hospital
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Menstruation Disturbances
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014