NCT00401193

Efficacy and Safety of XP12B in Women With Menorrhagia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic acid tablets	3900 mg/Day
DRUG	Tranexamic acid tablets	1950 mg/Day
DRUG	Placebo tablets

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-11-20
• Last updated: 2015-05-13
• Results posted: 2010-02-24

Locations

83 sites across 1 country: United States