Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids.

Aim: To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids.

Materials & Methods: This was a pooled analysis of two pivotal Phase III studies. Fibroids were evaluated by transvaginal ultrasonography.

Daily menstrual blood loss and quality of life in women with heavy menstrual bleeding.

Aim: Excessive blood loss during menstruation is a major problem for women of reproductive age. Women who experience heavy menstrual bleeding (HMB) often present to physicians because of the subsequent negative impact HMB has on their daily lives and activities. The objective of this post-hoc analysis is to evaluate daily menstrual blood loss (MBL) in women with HMB and assess the relationship between daily MBL and women's perceptions of MBL, limitations in physical activities and limitations in social/leisure activities as measured by the Menorrhagia Impact Questionnaire.

Tranexamic acid increases hemoglobin and ferritin levels in women with heavy menstrual bleeding.

Background: Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in women. A novel, modified-release oral formulation of tranexamic acid (TA) designed to reduce gastrointestinal side effects was approved recently for treatment of HMB. We assessed improvements in objective laboratory measures of IDA in women with self-reported HMB who received long-term TA therapy.

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).

A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding.

Objective: We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding.

Study Design: This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.