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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗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.
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