Trial record 6 of 996 for:    menstruation OR menstrual cycle AND NICHD

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 22, 2014
Last verified: July 2014
  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 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 2015
Estimated Primary Completion Date: April 2015 (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 (3 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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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 inability to complete study procedures
  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 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. 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 ClinicalTrials.gov identifier: NCT01846507

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

Locations
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44302
Contact: Jill Bradisse    330-543-3805    jbradisse@chmca.org   
Principal Investigator: Stephanie Savelli, MD         
Rainbow Babies & Children's Hospital 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: July 22, 2014
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 September 16, 2014