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Last Updated: October 24, 2020

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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.
NCT01659008 Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding Recruiting American College of Obstetricians and Gynecologists N/A 2012-06-01 Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding
NCT01659008 Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding Recruiting Kay I Waud MD PhD N/A 2012-06-01 Treatment with Estradiol is non-inferior to treatment with Tranexamic acid in reducing the amount and duration of menstrual blood loss in women with cyclic heavy menstrual bleeding
NCT01846507 Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding Recruiting Nationwide Children's Hospital Phase 4 2013-04-01 This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life. Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents. Tranexamic acid is taken orally during the first 5 days of menstrual bleeding. The purposes of this study include: To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life. Lysteda has been approved by the Food and Drug Administration for use in patients > than 18 years of age but not for younger patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lysteda

Condition Name

Condition Name for Lysteda
Intervention Trials
Heavy Menstrual Bleeding 5
Menorrhagia 5
Blood Loss, Surgical 3
Postoperative Wound Haemorrhage 1
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Condition MeSH

Condition MeSH for Lysteda
Intervention Trials
Hemorrhage 11
Menorrhagia 8
Blood Loss, Surgical 3
Osteoarthritis 2
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Clinical Trial Locations for Lysteda

Trials by Country

Trials by Country for Lysteda
Location Trials
United States 96
United Kingdom 1
Australia 1
Brazil 1
Mexico 1
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Trials by US State

Trials by US State for Lysteda
Location Trials
California 4
Ohio 4
Tennessee 3
Indiana 3
Louisiana 3
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Clinical Trial Progress for Lysteda

Clinical Trial Phase

Clinical Trial Phase for Lysteda
Clinical Trial Phase Trials
Phase 4 5
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Lysteda
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Lysteda

Sponsor Name

Sponsor Name for Lysteda
Sponsor Trials
Ferring Pharmaceuticals 4
Shannon K. Laughlin-Tommaso 1
American College of Obstetricians and Gynecologists 1
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Sponsor Type

Sponsor Type for Lysteda
Sponsor Trials
Other 16
Industry 4
NIH 1
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