CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 288 enrolled
Drug / intervention
Tranexamic aciddrug
Likely dose
Tranexamic acid 1.3 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01280981
NCT01280981Phase 3Completed
CompareCT.gov

A Multi-center, Open Label Extension Study to Evaluate the Safety of an Oral Dose of Tranexamic Acid (XP12B) Administered Three Times Daily During Menstruation for the Treatment of Menorrhagia

Ferring Pharmaceuticals·interventional·Posted Jan 21, 2011·Updated Jul 26, 2011

In Brief

A Phase 3 clinical trial evaluating Tranexamic acid for Menorrhagia. Completed, enrolled 288 participants across 92 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
CountriesUnited States
CollaboratorsXanodyne Pharmaceuticals

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2011
Enrollment StartApr 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.4 years ago

Interventions

Tranexamic aciddrug

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.