A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding

American Journal of Obstetrics and Gynecology
Ellen W FreemanTammie L Adomako

Abstract

We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding. This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.95 g/d or 3.9 g/d of tranexamic acid or placebo for up to 5 days of menstrual bleeding. Primary efficacy endpoints were mean MBL reduction from baseline, mean MBL reductions that were considered "meaningful" by subjects, and mean MBL reductions from baseline > 50 mL/cycle. Adverse events (AEs) were also assessed. Only the 3.9 g/d group met all 3 primary efficacy endpoints. AEs did not significantly differ among the 3 groups. There were no serious study-related AEs. The 3.9-g/d dose met all 3 primary efficacy endpoints, whereas the 1.95 g/d dose met 2 primary efficacy endpoints. Both doses were well tolerated.

Associated Clinical Trials

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Citations

Nov 3, 2012·Archives of Gynecology and Obstetrics·Hatem Abu Hashim
Apr 19, 2013·Archives of Gynecology and Obstetrics·Azita GoshtasebiSamira Behboudi Gandevani
Nov 28, 2012·Reviews in Endocrine & Metabolic Disorders·Joanna Davies, Rezan A Kadir
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Sep 1, 2012·Women's Health·Andrea S LukesTammie L Adomako
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Jul 20, 2012·The Annals of Pharmacotherapy·Sandra L Hrometz
Apr 16, 2018·The Cochrane Database of Systematic Reviews·Alison C Bryant-SmithMartha Hickey
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Jan 5, 2021·Frontiers in Physiology·Giris JacobBenjamin Brenner
Jun 15, 2021·EClinicalMedicine·Amani MeaidiOejvind Lidegaard

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