Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

NCT ID: NCT01846507

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Heavy Menstrual Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tranexamic acid

Subjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lysteda

Eligibility 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 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sarah O'Brien

Director of Experimental Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah O'Brien, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Akron Children's Hospital

Akron, Ohio, United States

Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

NCH12-00822

Identifier Type: -

Identifier Source: org_study_id