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Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
NCT01846507 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01846507
The ClinicalTrials.gov registry entry for NCT01846507 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01846507 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Ohio, Indiana, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01846507?
The interventions under investigation include: Tranexamic Acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01846507?
This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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