A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
This was a multicenter, open-label extension study for subjects completing either of 2
pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment
phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g
administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.
After the last treatment period, a follow-up phone call occurred approximately 30 days (range
25 to 35 days) after the last dose of study drug.