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. 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. 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. 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.
