At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 enrolled
Drug / intervention
tranexamic aciddrug
Likely dose
tranexamic acid 0.65 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, 2-way Crossover, Pharmacokinetic Study of Lysteda (Xanodyne Modified-Immediate Release Tranexamic Acid) Tablets at 2 Doses in Fasting Adolescent Females With Evidence of Heavy Menstrual Bleeding
In Brief
A Phase 4 clinical trial evaluating tranexamic acid for Menorrhagia. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionApr 2011
TodayJul 2026
First PostedAug 27, 2010
Enrollment StartAug 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.8 years ago
Interventions
tranexamic aciddrug
Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.