Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
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.
|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|
- 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.
- 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.
|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)|
Drug: Tranxemic Acid
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.
|Contact: Heidi Ziegler, RNemail@example.com|
|United States, Ohio|
|Akron Children's Hospital||Not yet recruiting|
|Akron, Ohio, United States, 44302|
|Contact: Ali Dawn 330-543-3805 firstname.lastname@example.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 email@example.com|
|Principal Investigator: Sanjay Ahuja, MD|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Heidi Ziegler, RN 614-722-3883 firstname.lastname@example.org|
|Principal Investigator: Sarah O'Brien, MD, MSc|
|Principal Investigator:||Sarah O'Brien, MD, MSc||Nationwide Children's Hospital|