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Completed Phase 4 Interventional Results available

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

ClinicalTrials.gov ID: NCT01846507

Public ClinicalTrials.gov record NCT01846507. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01846507
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
32 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 19 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2013
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016
Last update posted
Oct 23, 2018

2013 – 2016

United States locations

U.S. sites
5
U.S. states
3
U.S. cities
5
Facility City State ZIP Site status
Riley Hospital for Children at IU Health Indianapolis Indiana 46202
Children's Mercy Hospital Kansas City Missouri 64108
Akron Children's Hospital Akron Ohio 44302
Rainbow Babies & Children's Hospital Cleveland Ohio 44106
Nationwide Children's Hospital Columbus Ohio 43205

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01846507, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 23, 2018 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01846507 live on ClinicalTrials.gov.

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