Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid

Women's Health
Ken MuseEdward Trott

Abstract

A multicenter, long-term, open-label study was conducted to assess the safety and health-related quality of life (HRQoL) of an oral tranexamic acid (TA) formulation in women with cyclic heavy menstrual bleeding (HMB). Following a screening menstrual cycle, women with a history of cyclic HMB initiated 27 cycles of treatment with TA 1.3 g administered three-times daily for up to 5 days per menstrual cycle (maximum of 15 doses). Safety was assessed by treatment-emergent adverse event (TEAE) monitoring, physical examinations, laboratory results, ophthalmologic examinations and electrocardiography. HRQoL was evaluated using both generic and HMB-specific instruments. Most of the TEAEs were mild to moderate in severity and were largely considered unrelated to study treatment. The most commonly reported TEAEs among women in the intent-to-treat population (n = 723) were headache, menstrual discomfort and back pain. Improvements in generic and disease-specific HRQoL measures were evident during the first treatment cycle and were maintained throughout the 15 cycles of measurement for most domains. Long-term TA treatment was well tolerated and improved measures of HRQoL in women with cyclic HMB.

Associated Clinical Trials

References

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Citations

Sep 8, 2012·International Journal of Women's Health·Henri Leminen, Ritva Hurskainen
Sep 1, 2012·Women's Health·Andrea S LukesTammie L Adomako
Mar 21, 2012·Journal of Women's Health·Ken MuseTammie L Adomako
Jul 28, 2012·Current Medical Research and Opinion·Kenneth E Fox
Jul 9, 2013·British Journal of Haematology·Menaka PaiRonald Barr
Jul 20, 2012·The Annals of Pharmacotherapy·Sandra L Hrometz
Apr 21, 2018·Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [et Al.]·Harini R BalaMichelle Rodrigues
Apr 26, 2019·Current Opinion in Obstetrics & Gynecology·Jordan S KlebanoffGaby N Moawad
Mar 19, 2014·The Journal of Pharmacology and Experimental Therapeutics·Nikita JoshiJames P Luyendyk
Jun 16, 2021·Stroke; a Journal of Cerebral Circulation·Chloe A MutimerRobert L Medcalf
Jun 20, 2021·International Journal of Pediatric Otorhinolaryngology·Dylan Z ErwinAndrew D Meyer

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Methods Mentioned

BETA
contraception
hysterectomy

Clinical Trials Mentioned

NCT00113568

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