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

OBJECTIVE

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

Long-term TA treatment was well tolerated and improved measures of HRQoL in women with cyclic HMB.