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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: Completed Phase 4 study of Heavy Menstrual Bleeding, sponsored by Nationwide Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
What the finished NCT01846507 record still lists
NCT01846507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 222-participant average among 9 other Heavy Menstrual Bleeding trials with a reported enrollment target (86% lower).
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 lists 5 locations in 3 states (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.
Learn More About Clinical Trials
Similar trials for Heavy Menstrual Bleeding
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Where NCT01846507's enrollment target sits among peer trials
32 8th of 9 higher than 2 of 9 other Heavy Menstrual Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heavy Menstrual Bleeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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