Trials / Completed
CompletedNCT01190150
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 12 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tranexamic acid | 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. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2010-08-27
- Last updated
- 2012-07-16
- Results posted
- 2012-07-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01190150. Inclusion in this directory is not an endorsement.