At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
Tranexamic acid tablets +2 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.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
In Brief
A Phase 3 clinical trial evaluating Tranexamic acid tablets and Placebo tablets for Menorrhagia and Heavy Menstrual Bleeding. Completed, enrolled 304 participants across 83 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
Enrollment StartNov 2006
First PostedNov 2006
Primary CompletionMay 2008
TodayJul 2026
First PostedNov 20, 2006
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.6 years ago
Interventions
Tranexamic acid tabletsdrug
3900 mg/Day
Tranexamic acid tabletsdrug
1950 mg/Day
Placebo tabletsdrug