Efficacy and Safety Study of XP12B in Women With Menorrhagia
Completed
Ferring Pharmaceuticals
Phase 3
2006-10-01
The purpose of this study is to determine whether XP12B is effective and safe in the
treatment of women with heavy menstrual bleeding associated with menorrhagia.
Efficacy and Safety of XP12B in Women With Menorrhagia
Completed
Ferring Pharmaceuticals
Phase 3
2006-11-01
The purpose of this study is to determine whether XP12B is effective and safe in the
treatment of women with heavy menstrual bleeding associated with menorrhagia.
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
Completed
Ferring Pharmaceuticals
Phase 4
2010-08-01
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.
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Completed
Xanodyne Pharmaceuticals
Phase 3
2007-04-01
This was a multicenter, open-label extension study for subjects completing either of 2
pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment
phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g
administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.
After the last treatment period, a follow-up phone call occurred approximately 30 days (range
25 to 35 days) after the last dose of study drug.
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