Phase 3
Completed N=304
Efficacy and Safety of XP12B in Women With Menorrhagia
Menorrhagia · Heavy Menstrual Bleeding
Source: ClinicalTrials.gov NCT00401193 ↗
Enrolled (actual)
304
Serious AEs
0.7%
Results posted
Feb 2010
Primary outcomePrimary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 65; 44; 7 mL
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.
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 | — |
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. Informational only — not medical advice.