NCT00113568

Safety Study of XP12B in Women With Menorrhagia

Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 784 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Conditions

• Menorrhagia
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic acid tablets (XP12B)	Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-06-09
• Last updated: 2010-06-15
• Results posted: 2010-01-20

Locations

59 sites across 1 country: United States