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


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


Feb 1, 1995·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·D A RutaI T Russell
Jan 15, 2002·European Journal of Obstetrics, Gynecology, and Reproductive Biology·U H Winkler
Jan 16, 2002·JAMA : the Journal of the American Medical Association·David W KaufmanAllen A Mitchell
Jun 27, 2003·Drugs·Keri Wellington, Antona J Wagstaff
May 30, 2007·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Zhimei LiuRobert W Dubois
Jul 19, 2008·Fertility and Sterility·Kristen A MattesonMelissa A Clark
Jan 15, 2009·Haemophilia : the Official Journal of the World Federation of Hemophilia·C A Lee
Aug 21, 2009·Archives of Gynecology and Obstetrics·Sérgio Simões de SouzaAgnaldo Lopes Silva Filho
Sep 23, 2010·Obstetrics and Gynecology·Andrea S LukesGary A Shangold

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