NCT00453349

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

A Prospective, Randomized, Double Dummy, Double Blind, Multi-center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)

Conditions

• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
DRUG	Moxifloxacin (Avelox, BAY12-8039)	Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
DRUG	Levofloxacin & Metronidazole	Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-03-28
• Last updated: 2014-09-08
• Results posted: 2009-11-30

Locations

13 sites across 7 countries: China, Indonesia, Pakistan, Philippines, South Korea, Taiwan, Thailand