CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 784 enrolled
Drug / intervention
Tranexamic acid tablets (XP12B)drug
Likely dose
Tranexamic acid 3900 mg/day (two 650 mg tablets three times daily) for up to 5 days during menstruationAI-extracted
Key inclusion· 3
  • ✓Women with menorrhagia
  • ✓Age 18-49 years
  • ✓Regularly occurring menstrual periods
Key exclusion· 2
  • ✕History or presence of clinically significant disease or abnormalities that might confound the study
  • ✕History of bilateral oophorectomy or hysterectomy

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

Search/NCT00113568
NCT00113568Phase 3Completed
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Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

Ferring Pharmaceuticals·interventional·Posted Jun 9, 2005·Updated Jun 15, 2010

In Brief

A Phase 3 clinical trial evaluating Tranexamic acid tablets (XP12B) for Menorrhagia and Heavy Menstrual Bleeding. Completed, enrolled 784 participants across 59 sites.

Detailed Summary

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia, Heavy Menstrual Bleeding
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 9, 2005
Enrollment StartJun 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 21.1 years ago

Interventions

Tranexamic acid tablets (XP12B)drug

Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation