Phase 3 N=196 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of XP12B in Women With Menorrhagia

Menorrhagia · Heavy Menstrual Bleeding

Bottom Line

View on ClinicalTrials.gov: NCT00386308 ↗

Enrolled (actual)

196

Serious AEs

2.7%

Results posted

Feb 2010

Primary outcome: Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 66; 18 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)	66; 18	—
SECONDARY Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding	0.9; 0.4	—
SECONDARY Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding	0.9; 0.4	—
SECONDARY Responder Analysis - Reduction in Large Stains	57; 51	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00386308). 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.