Status:
COMPLETED
Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Heavy Menstrual Bleeding
Eligibility:
FEMALE
10-19 years
Phase:
PHASE4
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 increas...
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 re...
Eligibility Criteria
Inclusion
- Menstruating females 10-19 years of age
- Non-smoker
- Physician and patient have agreed to initiate Lysteda
- Diagnosis of HMB based on the medical judgment of the principal or site investigator
- Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period
- Negative pregnancy test
- Informed consent obtained and signed
- Informed assent obtained and signed
- Understanding of study procedures
- Ability to comply with study procedures for the entire length of the study
- 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
- 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
- Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance
- 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.
- Pregnancy within the past 6 months and/or breast-feeding
- 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
- Use of systemic steroids within 1 month of study entry
- History of subarachnoid hemorrhage
- History of Hepatitis B, C, or HIV
- Baseline creatinine \>20% above the upper limit of normal for age
- Severe anemia (hemoglobin \<8 g/dL)
- Systolic blood pressure \<85 or diastolic blood pressure \<55
- Heart rate \<50 at time of screening
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01846507
Start Date
April 1 2013
End Date
November 1 2016
Last Update
October 24 2018
Active Locations (5)
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1
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Akron Children's Hospital
Akron, Ohio, United States, 44302
4
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106