Phase 3
N=304
Efficacy and Safety of XP12B in Women With Menorrhagia
Menorrhagia · Heavy Menstrual Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT00401193 ↗Enrolled (actual)
304
Serious AEs
0.7%
Results posted
Feb 2010
Primary outcome: Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 65; 44; 7 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic acid tablets (Drug); Placebo tablets (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Reduction From Baseline in Menstrual Blood Loss (MBL) |
65; 44; 7 | — |
| SECONDARY Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding |
1.0; 0.4 | — |
| SECONDARY Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding |
0.9; 0.3 | — |
| SECONDARY Responder Analysis - Reduction in Large Stains |
64; 52 | — |
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.
Eligibility Criteria
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 for birth control
Data sourced from ClinicalTrials.gov (NCT00401193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.