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NCT01846507 · ClinicalTrials.gov registry record · Phase 4

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

A Phase 4 study of Heavy Menstrual Bleeding, sponsored by Nationwide Children's Hospital.

Completed
Registry status
Phase 4
Development phase
32
Enrollment target
5
Study locations

NCT01846507 is a Phase 4 study of Heavy Menstrual Bleeding that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 32 participants, below the 222-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT01846507, a Phase 4 study of Heavy Menstrual Bleeding, has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
32 participants
Enrollment target
5
Study locations

Study 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.

Conditions Studied

Heavy Menstrual Bleeding

Interventions

  • DRUG Tranexamic Acid

Study Locations (5)

Ohio

  • Akron Children's Hospital - Akron
  • Rainbow Babies & Children's Hospital - Cleveland
  • Nationwide Children's Hospital - Columbus

Indiana

  • Riley Hospital for Children at IU Health - Indianapolis

Missouri

  • Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2013-04
Est. Completion 2016-11
Phase Phase 4

Sponsor

Nationwide Children's Hospital

188 total trials

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What the Registry Record Tells You About NCT01846507

The ClinicalTrials.gov registry entry for NCT01846507 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (86% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heavy Menstrual Bleeding appearing as the primary indexed condition, and to 1 intervention - of which Tranexamic Acid is the first listed.

NCT01846507 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Indiana, Missouri.

Frequently Asked Questions

What is clinical trial NCT01846507 about?

NCT01846507 is a clinical study titled "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 w...

What is the current status of trial NCT01846507?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2013-04. Estimated completion is 2016-11.

What conditions does trial NCT01846507 study?

This clinical trial studies the following conditions: Heavy Menstrual Bleeding.

What interventions are being tested in trial NCT01846507?

The interventions under investigation include: Tranexamic Acid (DRUG).

Who is sponsoring clinical trial NCT01846507?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01846507 being conducted?

This trial has 5 study locations across Indiana, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.