Safety of Tranexamic Acid in Women with Heavy Menstrual Bleeding: An Open-Label Extension Study

AIMS: An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding. PATIENTS & METHODS: Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle). Safety was assessed by the incidence of treatment-emergent adverse events, ophthalmologic examinations and ECGs, among other evaluations. RESULTS: The most commonly reported treatment-emergent adverse events were menstrual discomfort (46.2%), headache (43.9%) and back pain (23.1%). A small proportion of participants (3.8%) reported ocular adverse events, but there was no evidence of ocular toxicity. No prothrombotic effects were observed. CONCLUSION: During nine menstrual cycles of treatment, this novel formulation of TA was well tolerated and exhibited a favorable safety profile supporting its use as a therapy for cyclic heavy menstrual bleeding.