CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
Tranexamic acid tablets +1 moredrug
Likely dose
Tranexamic acid tablets 3900 mgfrom 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/NCT00386308
NCT00386308Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

Ferring Pharmaceuticals·interventional·Posted Oct 11, 2006·Updated May 4, 2011

In Brief

A Phase 3 clinical trial evaluating Tranexamic acid tablets and Placebo tablets for Menorrhagia and Heavy Menstrual Bleeding. Completed, enrolled 196 participants across 52 sites.

Detailed Summary

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of 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
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.7 years ago

Interventions

Tranexamic acid tabletsdrug

3900 mg/Day

Placebo tabletsdrug