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NCT01190150 · ClinicalTrials.gov registry record · Phase 4

Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding

A Phase 4 study, sponsored by Ferring Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target

NCT01190150 is a Phase 4 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 20 participants.

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The verdict

NCT01190150, a Phase 4 study, has completed, sponsored by Ferring Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.

Interventions

  • DRUG tranexamic acid

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-08
Est. Completion 2011-04
Phase Phase 4

Sponsor

Ferring Pharmaceuticals

83 total trials

What the Registry Record Tells You About NCT01190150

The ClinicalTrials.gov registry entry for NCT01190150 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which tranexamic acid is the first listed.

NCT01190150 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01190150 about?

NCT01190150 is a clinical study titled "Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding". This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.

What is the current status of trial NCT01190150?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01190150?

The interventions under investigation include: tranexamic acid (DRUG).

Who is sponsoring clinical trial NCT01190150?

This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.

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.