A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Menorrhagia

Clinical Trial Details

NCT number	NCT01280981
Study type	Interventional
Source	Ferring Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	April 2007
Completion date	May 2009

View Details

See also
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