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 younger patients.
|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:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Drug: Tranexamic Acid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846507
|Contact: Heidi Ziegler, RNfirstname.lastname@example.org|
|United States, Ohio|
|Akron Children's Hospital||Recruiting|
|Akron, Ohio, United States, 44302|
|Contact: Jill Bradisse 330-543-3805 email@example.com|
|Principal Investigator: Stephanie Savelli, MD|
|Rainbow Babies & Children's Hospital||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Janet Martin, RN 216-844-6127 firstname.lastname@example.org|
|Principal Investigator: Sanjay Ahuja, MD|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Heidi Ziegler, RN 614-722-3883 email@example.com|
|Principal Investigator: Sarah O'Brien, MD, MSc|
|Principal Investigator:||Sarah O'Brien, MD, MSc||Nationwide Children's Hospital|