Conditions: Menorrhagia
Keywords: Menorrhagia Heavy Menstrual Bleeding Lysteda
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 288
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).

Interventions: intervention 1: Tranexamic acid
Intervention descriptions: intervention 1: 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 for 9 menstrual periods.

Protocol document: