CLINICAL TRIALS PROFILE FOR LYSTEDA
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All Clinical Trials for LYSTEDA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00113568 ↗ | Safety Study of XP12B in Women With Menorrhagia | Completed | Ferring Pharmaceuticals | Phase 3 | 2005-06-01 | The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia. |
| NCT00386308 ↗ | 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. |
| NCT00401193 ↗ | 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. |
| NCT01190150 ↗ | 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. |
| NCT01280981 ↗ | 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. |
| NCT01280981 ↗ | A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding | Completed | Ferring 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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