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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: Completed Phase 4 study, sponsored by Ferring Pharmaceuticals.
NCT01190150 is a Phase 4 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax is the maximum measured plasma concentration over the time-span specified.
Interventions
- DRUG tranexamic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
What the finished NCT01190150 record still lists
NCT01190150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which tranexamic acid is the first listed.
NCT01190150 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190150's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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