Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study

Subjects were randomized to one of two groups (group A or B). Group A received oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles. Group B received combined oral contraceptive pills (OCP) with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles. After 3 cycles of therapy, both groups had one cycle without any therapy. Then, the groups crossed over. Group A, who first received TA, then received OCP. Group B, who first received OCP, then received TA. All subjects were to receive both tranexamic acid and oral contraceptive pills. There were a total of 3 study-associated visits per patient: 1 at baseline and 2 at the end of 3 cycles on each medication. These visits were considered within standard of care, as subjects with menorrhagia have frequent monitoring until the effectiveness of the treatment is determined. At the study visits the following were done: 1. Assessment of the last menstrual period (amount of blood lost) using the Pictorial Blood Assessment Chart (PBAC) score and the number of days the period lasted 2. Quality of Life evaluation - by the patient completing a standardized pediatric quality of life (PedsQL) questionnaire 3. Detailed history and physical examination to evaluate for drug side effects and to look for signs of blood clots. 4. Blood drawn for a complete blood count.