NCT00386308CompletedPhase 3
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with menorrhagia
- •18-49 years of age
- •Regularly occurring menstrual periods
Exclusion Criteria
- •History or presence of clinically significant disease or abnormalities that may confound the study
- •History of bilateral oophorectomy or hysterectomy
- •Hormone therapy
Arms & Interventions
1
Experimental
Intervention: Tranexamic acid tablets (Drug)
2
Placebo Comparator
Intervention: Placebo tablets (Drug)
Outcomes
Primary Outcomes
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
Time Frame: Baseline MBL over 6 menstrual cycles
reduction of menstrual blood loss in mL
Secondary Outcomes
- Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding(Change from Baseline scores over 6 menstrual cycles)
- Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding(Change from Baseline scores over 6 menstrual cycles)
- Responder Analysis - Reduction in Large Stains(Reduction from Baseline over 6 menstrual cycles)
Investigators
Study Sites (1)
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