NCT01280981

A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

A Multi-center, Open Label Extension Study to Evaluate the Safety of an Oral Dose of Tranexamic Acid (XP12B) Administered Three Times Daily During Menstruation for the Treatment of Menorrhagia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2011-01-21
• Last updated: 2011-07-26
• Results posted: 2011-07-26

Locations

92 sites across 1 country: United States